Consent Decree - Recall

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs

Contact:
Jack Gindi
1-917-831-5948

[email protected]

Media:
Jack Gindi
1-917-831-5948

[email protected]

FOR IMMEDIATE RELEASE — December 27, 2017 – Ocean Township, NJ.  In accordance with a Consent Decree of Permanent Injunction ordered in the United States District Court for the District of New Jersey, Flawless Beauty, LLC is voluntarily recalling all lots of nineteen different products sold individually or as part of multi-unit kits alleged by the U.S. Food and Drug Administration (“FDA”) to be misbranded or unapproved new drugs pursuant to the Federal Food, Drug, and Cosmetic Act. The FDA believes that these drugs present serious public health risks. To date, Flawless Beauty has not received any reports of adverse events related to this recall.

The following products are subject to the recall and were sold and distributed over the Internet to U.S. and foreign customers. The web site of Flawless Beauty is www.flawlessbeautyandskin.com.  All glutathione products were sold in multi-vial whitening kits, either alone or in combination with ampules of vitamin C and sterile water. Vials or ampules of vitamin C or sterile water purchased separately or as part of these whitening kits are also recalled:

Return Response Form

Flawless Beauty is notifying its customers by sending recall letters and is arranging for return of all recalled products. Consumers, distributors & retailers that have the products which are being recalled should stop using & return to Flawless Beauty. 

Consumers with questions regarding this recall can contact Flawless Beauty by phone at 1-917-831-5948 or [email protected] on Monday-Friday, 9:30AM – 5:30 PM, EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products.

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.html
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.html or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being made with the knowledge of the Food and Drug Administration. 

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IN TI-IE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF NEW JERSEY

UNITED ST A TES OF AMERICA,

Plaintiff,

v

Case No. ~q I ( P&s)

FLAWLESS BEAUTY LLC, and

RDG IMPORTS LLC,

limited liability companies, and

JACK H. GrNDl, and

SUSANA B. BOLECHE, individuals,

Defendants.

..---~~~~~..---~~~~~~~~~~)

RECEIVED

SEP 2-6 2017

AT 8:30 M

WILLIAM T. WALSH

CLERK

CONSENT DECREE OF PERMANENT INJUNCTION

Plaintiff, the United States of America, ~y its undersigned attorneys, having tiled a

Complaint for Permanent Injunction against Flawless Beauty LLC ("Flawless") and ROG

Imports LLC C'RDG"), limited liability companies, and Jack H. Gindi, and Susana B. Boleche,

individuals (collectively, \1Dcfcndants'1

), and Defendants solely for the purposes of settlement of

this case, and without admitting or denying the allegations in the Complaint, having appeared

and having consented to entry of this Decree without contest and before any testimony has been

taken, and the Un itcd States of America, having consented to this Decree;

IT IS HEREBY ORDERED. ADJUDGED. AND DECREED as follows:

l. This Court has jurisdiction over the subject matter of tMs action pursuant to 21

U.S.C. § 332 and its inher~nt equitable authorityJ and has personal jurisdiction over all parties to

this action.

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2. The Complaint for Permanent Injunction states a cause of action against

Defendants under the Federal Food, Drug, and Cosmetic Act, 21 lJ.S.C. §§ 301 et seq. (the

"Act").

3. The CQmplaint alleges that Defendants violate 21 U.S.C. § 33 t (d) by introducing

or delivering for introduction, or causing to be introduced or delivered for introduction, into

·interstate commerce new drugs within the meaning of 21 U.S.C. § 321(p) that are neither

approved under 21 U.S.C. § J55(a) or U), nor exempt from approval under 2 J U.S.C. § 35S(i).

4. The Complaint alleges that Defendants violate 21 U.S.C. § 331 (a) by introducing

or delivering for introduction, or causing to be introduced or delivered for introduction~ into

interstate commerce articles of drugs that are misbranded within the meaning of 21 U.S.C. §§

352(a), 352(f)(l), 353(b)(l), and 353(b}(4).

5. The Complaint .alleges that Defendants violate 21 U.S.C. § 33 J (k) by causing

articles of drugs that they hold for sale after shipment in !nterstate commerce to become

misbranded within the meanjng of 21 U.S.C. §§ 352(a), 352(f)(1), 353(b)(l ), and 353(b)(4).

6. Upon entry of this Decree, Defendants and each and all of their directors, officers,

agents, representatives, employees, attorneys, successors, and assigns, and any persons in active

concert or participation with any of them (including individuals, directors, partnerships,

corporations, subsidiaries, affiliates, and "doing business as" entities) (collectively, "Associated

Persons .. )~ who receive notice of this Decree by personal service or otherwise, arc pennanentJy

restrained and enjoined under 21 U.S.C. § 332(a), and the inherent equitable authority of this

Court, from directly 01· indirectly importing, receiving, manufacturing, preparing~ processing,

packing, labeling, holding,. and/or distributing any articles of drug~ unless and until:

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(A) An approved new drug application, an abbreviated new drug application,

or an investigational new drug application filed pursuant to 21 U.S.C. 355 §§ (a), (j), or

(i) is in effect for such drugs; or

(B) Defendants retain, at Defendants' expense, an independent person or

persons (the "Expert"), who is without any personal or financial ties (other than the

retention agreement) to Defendants and/or their families, and who, by reason of

. background, training, education, and experience, is qualified to review the claims

Defendants make for each of their drug products on all labels, labeling, promotional

materials, and websites owned, controlled by, or reJated to Defendants, including, but not

limited to: www.tlawlessbeautyandskin.com; www.relumins.com; Defendants' Google+

page; Defendants1 Facebook page; and Defendants' postings on eBay, Amazon. and other

on)ine marketplace websites (coJJectiveJy, ~'Defendants' websites");

(1) Defendants shall notify the United States Food and Drug

Administration (''FDA'') in writing of the identity and qualifications of the Expert

as soon as they retain the Expert;

(2) The Expert shall perform a comprehensive review of Defendant's

compliance with the Act, its impJementing regulations, and this Decree; and

(3) Defendants and/or the Expert shall remove aJI cfajms that cause

Defendants' products to be unapproved new drugs from all labels, labeling.

including promotional materials, Defendants' websites~ and any other sources

owned or controlled by or related to Defendants and/or their articles of dn1g; mid

(C) The Expert certifies to FDA in a written repot1 a list of the materials he or

she has reviewed, including. but not limited to, all labels. labeling, including promotional

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materials and websites, and any other sources owned or controlled by or related to

Defe,ndants and/or their articles of drug, and whether Defendants are operating in

compliance with the Act, its implementing regulations, and this Decree;

( l) The. report shall include copies of aJJ materials reviewed by the

Expert; and

(2) The Expert shoIJ submit the report concurrently to Defendants and

FDA no later than ten (10) calendar days after completing this review; and

(D) Should the Expert identify any deficiencies in his or her report described

in Paragraph 6(C):

(1) Defendants shall report to FDA and the Expert in writing the

actions they have taken to correct all such deficiencies; and

(2) The Expert shalJ certify in writing to FDA, based upon the

Expert's further review and/or inspection(s), whether Defendants have omitted all

claims from each of theJr product Jabe1s, labeling, including promotional

materials, Defendants' websites, and in any other source owned or controlled by

or related to Defendants and/or their articles of drug, which cause Defendants'

products to be dnigs under the Act; and

(E) Defendants shall provide FDA any additional information it requests after

FDA 's review of the Expert's report; and

(F) FDA representatives may also inspect Defendants~ facility to determine

whether the requirements of this Oecree have been met and whether Defendants arc

operating in confonnity with the Act, its implementing regulations. and this Decree. The

cost of FDA 's inspections under this Subparagraph shall be borne by Defendants at the

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rates specified in Paragraph 15. Such inspection, if any, wHJ be initiated within thhty (30)

business days after receiving the Expert report under Paragraph 6(C), Defendants'

corrective actions (if any) under Paragraph 6(D), and any materials. requested by the

agency under Paragnlph 6(E);

(G) FDA notifies Defendants in writing that they appear to be in compliance

with the requirements set forth in Subparagraphs 6(B) - (F).

7. Within twenty (20) calendar days of entry of this Decree, Defendants shall recall

and destroy, under FDA supervision and to FDA 's satisfaction, LingZhi Plus and any ampule or

lyophilized vial, including those sold as part of ~'whitening kits" or "kits" that Defendants

imported, manufactured, prepared, processed, packaged, labeled, held and/or distributed before

entry of this Decree, including, but not limited to: Relumins Vitamin C; Rehunins Advanced

Glutathione, including "whitening kits;u Relumins Solvent for Glutathione; Relumins Reduced

Glutathione Powder; TP Drug Laboratories Vitamin C; Tatiomax GJutathione; Tatiomax

Glutathione + Hydrolyzed CoJJagen, including "whitening kits;" Tatiomax Reduced Glutathione;

Tatiomax vials and powders; Saluta Glutathione; Saluta Reduced Glutathione; ''Sterile" Water

for injection; Laroscorbine Platinum Vitamin C with coJlagcn, including aJJ ''kits;" Tationil

GJutathione; Laennec Human Placenta Whitening; Reiki Glutathione Whitening~ and TAD.

Glutathione. Defendants shall, under FDA supervision and to FDA 's satisfaction. notify all

affected consumers of the recall. Defendanls shall not dispose of any drugs in a manner contrary

to the provisions of the Act, any other federal law, or the laws of any State or Territory in which

the drugs are disposed. Defendants shall bear the cost of the recall, destruction notification, and

FDA supervision. The cost of FDA 's participation and supervision under this Paragraph shall be

borne by Defendants at the rates specified in Paragraph IS.

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8. After Defendant~ have complied with Subparagraphs 6(8) - (F), and FDA has

notified Defendants in writing pursuant to Subparagraph 6(0), Defendants shall notify FDA on

the first day of each month, at the address specified in Paragraph 19 of this Order, of their intent,

if any, to market any FDA-regulated product(s) that were not included in the Expert report

submitted under Paragraph 6(C) f'New Products"). Such notification shall include the name of

each New Product and alJ proposed labels, labeling, and promotional materials for each New

Product. Defendants shall ensure that all such activity shalJ be in full compliance with this

Decree, the FDCA, and Hs implementing regulations.

9. After Defendants have complied with Subparagraphs 6(B) - (F), and FDA has

notified Defendants in writing pursuant to Subparagraph 6(0), Defendants shall retain an

independent person or persons (the .. Auditor'') at Defendants' expense to conduct audit

inspections of Defendants' drug products and their labeling, including Defendants' websites and

promotional materials, a~~ any other source owned or controlled by or related to Defendants

and/or their articles of drug, not less than once every.six (6) months for a period of five (5) years.

The Auditor shall be qualified by education, training, and experience to conduct such

inspections, and shaJJ be without personal or financial ties (other than a consulting agreement

with Defendants) to Defendants' officers or employees or their immediate families. The Auditor

may be the same person or persons described as the Expert in Subparagraph 6(8). AdditionaJJy:

(A) Defendants shall notify FDA in writing of the identity and qualifications

- of the Auditor as soon os they retain the Auditor;

(R) At the conclusion of each audit inspt:ction, the Auditor shall prepare a

written audit report (the "Audit Report0

) analyzing whether Defendants' drug products

and their labeling, including Defcndantsi websjtes, product labeling, and promotional

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materials, and any other source owned or controlled by or rc1ated to Defendants and/or

their articles of drug, are in compliance with the Act, its implementing regulations, and

this Decree, and identifying in detail any deviations from the foregoing ("Audit Report

Observations");

(C) Each Audit Repor1 shaJJ also contain a written certification that the

Auditor:

(I) has personally reviewed all of Defendants' drug products and their

labeling, including Defendants' websites and promotional materials, and any

other source owned or controJJed by or related to Defendants and/or their articles

of drug; and

(2) has personally certified whether all of Defendants' drug products

and their labeling, including Defendants' promotional materials and websites,

and any other source owned or controlled .by or related to Defendants and/or

their articles of drtig, comply with the requirements of the Act, its implementing

regulations, and this Decree;

(D) As part of every Audit Report, the Auditor shaJJ assess the adequacy of

corrective actions taken by Defendants to correct all previous Audit Report Observations;

(E) The Audit Reports shall be delivered contemporaneously to Defendants

and FDA by courier service or overnight delivery service, no later than ten (JO) calendar

days after the date the audit inspections are completed;

(F) If any Audit Reports identify any deviations from the Act, applicable

regulations, and/or this Decree, FDA may, in its discretion. require that the five (5) year

audjting cycle be extended or begin anew;

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(G) Defendants shall maintain complete Audit Reports and all of their

underJying data in separate files at their facilities and shall promptly make the Audit

Reports and underlying data available to FDA upon request; and

(H) If an Audit Report contains any adverse Audit Report Observations,

Defendants shall, within twenty (20) calendar days after receipt of the Audit Report,

correct those observations, unless FDA notifies Defendants that a shorter time period is

necessary. If, after receiving the Audit Report, Defendants believe that correction of any

adverse Audit Report Observation will take longer than twenty (20) calendar days,

Defendants shal1, within ten (10) calendar days after receipt of the Audit Report, propose

a schedule for completing corrections ("Correction Schedule'» and provide justification

for the additional time. The Correction Schedule must be reviewed and approved by

FDA in writing prior to implementation. Defendants shall compJete all corrections

according to the approved Correction Schedule. Within ten (10) calendar days after

Defendants' receipt of an Audit Report~ or within the lime period provided in a

Correction Schedule approved by FDA, the Auditor shall review the acti<.1ns taken by

Defendunts to correct the adverse Audit Report Observations. Within two (2) calendar

days after beginning that review, the Auditor shall report in writing to FDA whether each

of the adverse Audit Report Observations has been corrected and. if not, which adverse

Audit Report Observations remain uncorrected.

l 0. Upon entry of this Decree~ Defendants and all of their Associated Persons are

pcnnanently restrained and enjoined under the provisions of 21 U.S.C. § 332(a) from djrectly or

indire.ctly doing or causing to be done any act that:

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(A) Violates 2 J U.S.C. § 33 J (d) by introducing or delivering for introduction,

or causing to be introduced or delivered for introduction, into interstate commerce any

product that is a new drug within the meaning of 21 u.s.c. § 321(p) that is neither

approved under 21 U.S.C. § 355(a) or 0), nor exempt from approval under 21 U.S.C.

§ 355(i);

(B) Violates 21 U.S.C. § 33l(a) by introducing or delivering for introduction,

or causing to be jntroduced or delivered for introduction, into interstate commerce

articles of drug that are misbranded within the meaning of21 U.S.C. §§ 3S2(a), 352(f)(l),

353(b)(l), and 353(b)(4);

{C) Violates 21 U.S.C. § 33J(k) by causing articles of drug that Defendants

hold for sale after shipment in interstate commerce to become misbranded within the

meaning of 21 U.S.C. §§ 352(a), 352(1)(1), 353(b)(I), and 353(b)(4); and/or

(D) Fails to impJement and continuously maintain the requirements of this

Decree.

11. If, at any time after entry of this Decree. FDA determines, based on the results of

an inspection,. a report submitted by Defendants, the Expert, the Auditor, or any other

infonnation, that Defendants have failed to compJy with any provision of this Decree, the Act, or

its implementing regulations, or th~t. additional corrective actions are necessary to achieve

compliance with this Decree, the Act, or its implementing regulations, FDA may. as and when it

deems i1eccssary, notify Defendants in writing of the noncompliance .and order Defendants to

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take appropriate corrective action, including, but not limited to, ordering Defendants to

immediately take one or more of the following actions:

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(A) Cease importing, receivjng, manufacturing, preparing. processing,

packing, Jabeling, holding, selling, and/or distributing oil drug products;

(B) Recall and/or destroy, at Defendants' expense, any drug products that are

unapproved, misbranded, or otherwise in violation of this Decree, the Act, or its

implementing regulations;

(C) Revise, modify, expand, or continue to submit any reports or plans

prepared pursuant to this Decree;

(D) Submit additional reports or information to FDA as requested;

(E) Issue a safety alert; and/or

(F) Take any other co1Tective actions as FDA. in its discretion, deems

necessary to bring Defendants into compliance with this Decree, the Act, and its

implementing regulations.

The provisions of Paragraph 11 shall be apart from, and in addition to, aJI other remedies

available to FDA.

12. Upon receipt of any order issued by FDA pursuant to Paragraph 11, Defendants

shall immediately and fully comply with the tenns of the order. Any cessation of operations or

other action described in Paragraph 11 shall continue until Defendants receive written

notification from FDA that Defendants appear to be in compliance with this Decree, the Act, and

its implementing regulations, and that Defendants may resume operations. The cost of FDA

inspections, sampling, tescing, travel time, and subsistence expenses to implement the remedies

set forth in Paragraph 11 shall be borne by Defendants at the rates specified in Paragraph 15.

13. FDA shall be pcnnitt~d. without prior notice and when FDA deems necessary, to

make inspections of the Defendants' place(s) of business, and, without prior notice. take any

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other measures necessary to monitor_ and ensure continuing compliance with the tenns of this

Decree, the Act, and FDA regulations. During inspections, FDA shall be i)ermitted to have

immediate access to buildings, company~owned vehicles, equipment, products, labeling, and

other materials therein; take photographs and make video recordings; take samples of

Defendants' products, containers, packaging material, labeling, and other materials; and examine

and copy all records relating to the importing, receiving, manufacturing, preparing, processing,

packing, labeling, holding, and/or distributing all drugs. The inspections shall be permitted upon

presentation of a copy of this Decree and appropriate credentials. The inspection authority

granted by this Decree is separate from, and in addition to, the authority to make inspections

under the Act, 21 U.S.C. § 374.

14. Defendants shall promptly provide any information or records to FDA upon

request regarding the importing, receiving, manufacturing, preparing, processing, packing,

labeling, holding, and/or distribution of Defendants' products. Defendants shall submit, within

ten (J 0) calendar days, a copy of the materials FDA requests, including, but not limited to,

labels, labeling, promotional materials, downJoaded copies of any of Defendants' websites,

and/or any other sources owned or controlled by or related to Defendants and/or their articJes of

drug (on CD-ROM), to FDA at the address specified in Paragraph 19.

J 5. Defendants shall pay aJJ costs of all FDA inspections, investigations, analyses,

examinations, sampJing, reviews. document preparation, testing, travel. and subsistence expenses

that FDA deems necessary to evaJuatc Defendants' compliance: with any part of thjs Decree, at

the standard rates prevailing at the time costs are incurred, and Defendants shall make payment

in full lo the Unite.d States within twenty (20) calendar days of receiving written notification

from FDA of such costs. for the purposes of this Decree, inspections include, but are not limited

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to, FDA review and analysis of Ocfondants' product labels, labeling, protilotional materials,

Defendants' websites, and any other sources owned or controlled by or related to Defendants or

their articles of drug. As of the date of this Decree, these rates are: $93.26 per hour and fraction

thereof per representaiive for inspection or investigative work; $11 l.77 per hour or fraction

thereof per representative for analytical or review work; $0.535 per mile for travel by motor

vehicle; government rate or the equivalent for travel by air or other means; and the published

government per diem rate or the equivalent for the areas in which the inspections are perfonned

, per day per representative and for subsistence expenses, where necessary. In the event that the

standard rates applicable to FDA supervision of court-ordered compliance are modified, these

rates shalJ be increased or decreased without further order of the Court.

16. Defendants shall provide notice of this Decree in the following manner:

(A) Within ten ( 10) calendar days after entry of this Decree, Defendants shall:

(1) Provide a copy of this .Decree, personally or, when necessary, by

certified mai I (return receipt requested) to all Associated Persons;

(2) Post a copy of this Decree both in a conspicuous 1ocation in a

common area at Defendants' facility and on Defendants• websites, and en.sure the

Decree remains posted for as long as the Decree remains in effect;

(3) Hold a general meeting or series of smaller meetings for all

employees, at which Defendants shall describe the tenns and obligations of this

Dt:cree; and

( 4) Provide to FDA a copy of the agenda, list of attendees, and

meeting minutes from the mt!eting(s) held pursuant to Subparagraph l 6(A)(3).

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(R) Within twen1y (20) calendar days after entry of this Decree, Defendants

shall provide to FDA an affidavit, from a person with personal knowledge of the facts

stated therein, stating the fact and manner of their compliance with Subparagraph 16(A).

17. li1 the event that any of the Defendants becomes associated with additional

Assoc.iated Persons at any time after entry of this Decree, Defendants immediately shall provide

a copy of this Decree, by persona) service or certified mail (restricted delivery, return receipt

rcqucsted)t to such Associated Persons;

(A) Each time Defendants become associated with an additional Associated

Person, they shall. within ten ( 10) c_alendar days, provide FDA an affidavit stating the

fact and manner of their compliance with Paragraph 17, identifying the names, addressest

and positions of an Associated Persons who received a copy of this Decree pursuant to

this Paragraph and the manner of such notification; and

(B) Within ten (10) calendar days of receiving a request from FDA for any

infonnation or documentation PDA deems necessary to evaluate compliance with

Paragraph 17, Defendants shall provide Sl,lch information or documentation to FDA.

18. Defendants shall notify FDA in writing at the address specified in Paragraph 19,

at Jeasl fifteen ( 15) calendar days before any change in ownership, charactcrt or name of their

business, such as disso)ution, assignment, or sale resulting in the emergence of a successor

corporation. the creation or dissolution of subsidiaries,_ franchises, affiliates, or "doing busi'ness

as" entities, or any other change in the org~nizationaJ structure of Flawless or RDG or in the sale

or assignment of any business assets. such as buildings, equipment, or inventory, that may affect

compliance with this Decree;

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(A) Defendants shall provide a copy of this Decree to any potential successor

or assignee at least fifteen ( 15) calendar days before any sale or assignment; and

(B) Defendants shall furnish FDA with an affidavit stating the fact and manner

of their compliance with Paragrdph 18 no later than ten (10) calendar days before such

assignment or change in ownership.

l 9. All notifications, certifications, reports, correspondence, and other

communications to FDA required under this Decree shall be addressed to the District Director,

,United States Food and Drug Administration, Office of Phannaceutical Quality Operations,

Division 1, l 0 Waterview Boulevard, Parsippany, 3rd Floor, New Jersey 07054, and shall

prominently reference this Consent Decree, the case name, and civil action number. Defendantc;

may also send courtesy copies of any notifications,. certifications, reports, correspondence, and

other communications to FDA required under this Decree to District Director, United States

Food and Drug Administration, Office of Pharmaceutical Quality Operations, Division I, at

orapharm 1opdiv1 [email protected].

20. If Defendants have maintained a state of continuous compliance with the law and

this Decree for at least 60 months after receiving FDAts notification under Paragraph 6(G),

Defendants may petition the Court for refief from this Decree, and the Government will not

oppose the petition.

21. Under no circumstances shall FDA 's silence be construed as a substitute for

written notification.

22. Should Defendants faj) to comply with any provi~ion of this Decree, the Act, or

its implementing regulations, they shall pay to the United States of America Ten Thousand

Dollars ($ J 0,000.00) in liquidated damages for each violation of this Decree, the Act, and/or its

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implementing regulations; an additional Three Thousand DolJars ($3;000.00) in liquidated

damages per day, per violation, for ench violation of t_his Decree, the Act, 11nd/or its

implementing regulations; and an amount equal to twice the retail value of any drugs distribut~d

in violation of the Act, jts implementing regulations, and/or this Decree. Defendants understand

and ab'T'ee that the liquidated damages specified in Paragraph 22 are not punitive in nature and

their imposition does not in any way limit Plaintiffs ahiJity to seek, and the Court to impose,

additional civil or criminal penalties based on conduct that may also be the basis for payment of

liquidated damages.

23. Should Plaintiff bring and prevail in a contempt action to enforce the terms of

this Decree, Defendants shaJJ, in addition to other remedies, reimburse Plaintiff for its attomeyst

fees and overhead, investigationaJ and analytical expenses, expert witness fees, travel expenses

incurred by attorneys and witnesses, and court costs or any other fees relating to such contempt

proceedings.

24. All decisions specified in this Decree shall be vested in the discretion of FDA.

FDA's decisions shaJI be final and, if challenged, shall be reviewed by the Court under the

arbitrary and capricious standard set forth in 5 U.S.C. § 706(2)(A). Review by the Court of any

FOA decision rendered pursuant to this Decree shall be based. exclusively on the written record

before FDA at the time the decision was made. No discovery shall be taken by either party.

25. This Decree resolves onJy the claims in this statutory injunction action brought

under 2 J U.S.C. § 3J2(a) as set forth in the Complaint. Defendants specifically state and agree

that entry of this Decree does not preclude any other civil, criminal: or administrative claims that

the government may have or may bring in the future against any of the Defendants herein in

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connection with, or relating to, any of the Defendants' activities involving FDA-regulated

products, incJuding the conduct alleged in the Complaint fl1ed with this Decree.

26. This Court retains jurisdiction of this action for the purpose of enforcing or

modifying this Decree and for the purpose of granting such additional relief as may be necessary

or appropriate.

SO ORDERED this __ ~ day of_~~' 2017.

__ _&;.(\~_

United States District Judge

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We hereby consent to the entry of the forgoing Decree:

Attorney for Defendants

FOR PLAINTIFF

CHAD A. READLER

Acting Assistant Attorney General

Of Counsel:

JEFFREYS. DA VIS

Acting General Counsel

REBECCA K. WOOD

Chief Counsel

Food and Drug Division

ANNAMARIE KEMPIC

Deputy Chief Counsel, Litigation

SONIA W. NATH

Associate Chief Counsel for Enforcement

United States Department of

Health and Human Services

Office of the General Counsel

Food and Drug Administration

J0903 New Hampshire Avenue

SHver Spring, MD 20993

Tel: 301.796.8708

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Case 3:17-cv-07091-PGS-TJB Document 3 Filed 09/26/17 Page 17 of 17 PageID: 89

Flawless Beauty and Skin Issues Voluntary USA Recall of Unapproved Drugs

Company Contact:
Jack Gindi
+1-917-653-3856

FOR IMMEDIATE RELEASE – 4/29/14 – Asbury Park, NJ, Flawless Beauty and Skin is voluntarily recalling eleven (11) lots of Roche Laroscrobine Platinum, Relumins Advanced Glutathione, QAF Pharmaceuticals Inc. Philippines Saluta Glutathione Rx, Tatiomax Reduced Glutathione + Hydrolyzed Collagen, TP Drug Laboratories Vitamin C, and Rx Sterile Water for Injection to the retail and consumer level. These products are currently unapproved drugs in the US.

These products claim to treat scurvy, degenerative brain and liver diseases, alcoholic liver disease, and serve as antidotes to various drugs. The label claims may result in patients not seeking proper medical treatment. Furthermore, the fact that these products may be administered intramuscularly or intravenously, heightens the risk associated with unknown quality, safety, or efficacy. To date, Flawless Beauty and Skin has not received any reports of adverse events related to this recall.

The following products were distributed in the US to wholesale, retail & Internet customers:

Flawless Beauty and Skin is notifying its distributors and customers by sending recall letters and is arranging for return of all recalled products. Consumers, distributors & retailers that have the products which are being recalled should stop using & return to Flawless Beauty and Skin.

Consumers with questions regarding this recall can contact Flawless Beauty and Skin by +1-917-831-5948 or [email protected] on Monday-Friday, 9:30AM – 5:30 PM, EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm¹
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm² or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.