Drug Recalls

MICHIGAN HERBAL REMEDIES

Class I Completed

A Clean Choice CBD, Hemp Oil Extract Tincture, Sweet Mint, 500mg, 1 fl oz (30 ml) bottles, Made in Michigan for A Clean Choice, A Division of A Clean Cigarette, Inc., 3055 Bay Rd Suite 1, Saginaw, MI ...

Reason: Chemical contamination: product contains elevated levels of undeclared lead.

D-1456-2020 August 12, 2020 Jenison, MI

MICHIGAN HERBAL REMEDIES

Class I Completed

BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Natural 500MG CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 156, Eau Claire, MI 49111

Reason: Chemical contamination: product contains elevated levels of undeclared lead.

D-1458-2020 August 12, 2020 Jenison, MI

MICHIGAN HERBAL REMEDIES

Class I Completed

BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Natural, 1000MG CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 156, Eau Claire, MI 49111

Reason: Chemical contamination: product contains elevated levels of undeclared lead.

D-1479-2020 August 12, 2020 Jenison, MI

MICHIGAN HERBAL REMEDIES

Class I Completed

Tasty Drops Hemp Oil Extract, Spearmint, 1 FL. OZ (30ML) bottles, 300MG CBD, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 8 02991 76472 1

Reason: Chemical contamination: product contains elevated levels of undeclared lead.

D-1449-2020 August 12, 2020 Jenison, MI

MICHIGAN HERBAL REMEDIES

Class I Completed

Tasty Drops, Hemp Oil Extract, Spearmint, 500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29081 1

Reason: Chemical contamination: product contains elevated levels of undeclared lead.

D-1473-2020 August 12, 2020 Jenison, MI

MICHIGAN HERBAL REMEDIES

Class I Completed

SP, hemp oil, Berry, 300MG CBD,1 FL. OZ (30 ML) bottles, Distributed by: The Spiffy Piff

Reason: Chemical contamination: product contains elevated levels of undeclared lead.

D-1465-2020 August 12, 2020 Jenison, MI

MICHIGAN HERBAL REMEDIES

Class I Completed

Acadia Farms, Serenity, soothing mint, 300 MG Hemp Oil, 1 Fl OZ (30 ML) bottles, Distributed by: Acadia Farms, Rehobeth, Massachusetts

Reason: Chemical contamination: product contains elevated levels of undeclared lead.

D-1469-2020 August 12, 2020 Jenison, MI

MICHIGAN HERBAL REMEDIES

Class I Completed

BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Spearmint, 500mg CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 156, Eau Claire, MI 49111

Reason: Chemical contamination: product contains elevated levels of undeclared lead.

D-1459-2020 August 12, 2020 Jenison, MI

MICHIGAN HERBAL REMEDIES

Class I Completed

Pathway To Wellness, CBD Oil, Premium Hemp Oil Drops, Natural, 1000MG CBD, 1 FL OZ (30 ML) bottles, Distributed by: Pathway to Wellness

Reason: Chemical contamination: product contains elevated levels of undeclared lead.

D-1464-2020 August 12, 2020 Jenison, MI

MICHIGAN HERBAL REMEDIES

Class I Completed

Tasty Drops, Hemp Oil Extract, Vanilla, 500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29082 8

Reason: Chemical contamination: product contains elevated levels of undeclared lead.

D-1476-2020 August 12, 2020 Jenison, MI

MICHIGAN HERBAL REMEDIES

Class I Completed

Goodness Gurus, Healthy Hemp Drops Full Strength, 1000 MG/Spearmint, 1 FL. OZ bottles, Distributed by: Goodness Gurus, Inc., Carlisle, PA, UPC 53341 99311 3

Reason: Chemical contamination: product contains elevated levels of undeclared lead.

D-1480-2020 August 12, 2020 Jenison, MI

UVT INC

Class I Terminated

Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by Polarized, LLC, Produced by Eskbiochem SA de CV, Mexico Japon 50, Celaya, Gto., Mexico, 38010. UPC 8 60003 63391 ...

Reason: Chemical Contamination: Product contains undeclared methanol.

D-1407-2020 August 5, 2020 Newport Beach, CA

SUN PHARMACEUTICAL INDUSTRIES INC

Class III Terminated

Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86

Reason: Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine

D-1445-2020 August 5, 2020 Princeton, NJ

Transliquid Technologies, LLC

Class I Terminated

Mystic Shield PROTECTION, ALCOHOL ANTISEPTIC 70%, Topical Solution, Antiseptic Hand Rub, Non-sterile Solution, Extra strength Formula*, 8.45 fl. oz. (250 ml) bottle, Labeled with green or blue labels,...

Reason: Chemical Contamination: Presence of Undeclared Methanol

D-1408-2020 July 29, 2020 Spring, TX

Akorn, Inc.

Class III Terminated

Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12

Reason: Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample

D-1388-2020 July 22, 2020 Lake Forest, IL

MasterPharm LLC

Class I Terminated

Finasteride Plus 1.25 mg Capsule, a) 30-count bottle, b) 90-count bottle, Compounded Product Not for Resale, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419.

Reason: Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain minoxidil.

D-1269-2020 May 20, 2020 South Richmond Hill, NY

Filltech USA, LLC

Class II Terminated

Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a) 1.5 fl. oz. (44 mL) tottles, UPC: 087052727338; b) 2 Fl. OZ. (59 mL) tubes, UPC:...

Reason: Microbial contamination of non-sterile products: positive test for yeast and bacteria.

D-1242-2020 April 22, 2020 Rockwell, NC

Filltech USA, LLC

Class II Terminated

Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 30, package in 1.5 fl. oz. (44 mL) tottles, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30...

Reason: Microbial contamination of non-sterile products: positive test for yeast and bacteria.

D-1241-2020 April 22, 2020 Rockwell, NC

Perrigo Company PLC

Class II Terminated

Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per bottle. [NDC: Brand] NDC H.E.B.: 37808-876-47; NDC Equate: 49035-876-47

Reason: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

D-1015-2020 March 25, 2020 Allegan, MI

Perrigo Company PLC

Class II Terminated

Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. [NDC: Brand] NDC Good Sense:0113-0852-51; NDC Walgreens 0363-0852-51

Reason: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

D-1017-2020 March 25, 2020 Allegan, MI

Perrigo Company PLC

Class II Terminated

Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-01; NDC CVS Health: 59779-950-01

Reason: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

D-1027-2020 March 25, 2020 Allegan, MI

Perrigo Company PLC

Class II Terminated

Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Being Well: 46994-852-62; NDC Care One 41520-392-02; NDC CVS Health: 59779-540-02; NDC DG Health:...

Reason: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

D-1018-2020 March 25, 2020 Allegan, MI

Perrigo Company PLC

Class II Terminated

Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-01; NDC Berkley Jensen: 68391-852-56; NDC: CVS Health: 59779-540-01; NDC DG...

Reason: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

D-1026-2020 March 25, 2020 Allegan, MI

Perrigo Company PLC

Class II Terminated

Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Care One: 41520-392-09; NDC CVS Health: 59779-540-09; NDC Family Wellness: 55319-852-09; NDC Good...

Reason: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

D-1022-2020 March 25, 2020 Allegan, MI

Perrigo Company PLC

Class II Terminated

Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Care One: 41520-609-62; NDC CVS Health: 59779-950-62; NDC DG Health: 55910-423-62; NDC ...

Reason: CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

D-1019-2020 March 25, 2020 Allegan, MI

FDA Enforcement Report