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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 6561–6580 of 17,773 recalls

Class IITerminated

Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per bottle. [NDC: Brand] NDC CVS Health.: 69842-293-06

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

October 23, 2019 · DrugView details →

Class IITerminated

Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-608-75; NDC Up & Up: 11673-023-75

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

October 23, 2019 · DrugView details →

Class IITerminated

Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-58

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

October 23, 2019 · DrugView details →

Class IITerminated

Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-82; NDC CVS Health: 59779-540-82; NDC HEB: 37808-507-82; NDC Signature Care: 21130-116-82; NDC Walgreens: 0363-0852-82

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

October 23, 2019 · DrugView details →

Class IITerminated

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 Equaline: 41163-950-62; NDC Family Wellness: 55319-523-62; NDC Good Neighbor Pharmacy: 46122-041-62; NDC HEB: 37808-710-02; NDC Kroger: 30142-891-02; NDC Leader: 70000-0378-1; NDC Meijer: 41250-950-02; NDC Rite Aid: 11822-0950-0; NDC Shopko: 37012-950-62; NDC Signature Care: 21130-568-62; NDC Topcare: 36800-950-62; NDC Walgreens: 0363-0950-02

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

October 23, 2019 · DrugView details →

Class IITerminated

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 Neighbor Pharmacy: 46122-532-09; NDC HEB: 37808-507-09; NDC Health Mart: 49348-109-54; NDC Meijer: 41250-891-09; NDC Rite Aid: 11822-0852-3; NDC Shopko: 37012-852-09; NDC Sound Body: 50594-852-09; NDC Sunmark: 49348-109-54; NDC Up & Up: 11673-852-09; NDC Walgreens: 0363-0852-09

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

October 23, 2019 · DrugView details →

Class IITerminated

Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-09; NDC CVS Health: 59779-950-09; NDC Equate: 49035-800-09; NDC Good Neighbor Pharmacy: 46122-533-09; NDC Kroger: 30142-891-09; NDC Topcare: 36800-950-09; NDC Up & Up: 11673-950-09; NDC Walgreens: 0363-0950-09

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

October 23, 2019 · DrugView details →

Class IITerminated

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

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

October 23, 2019 · DrugView details →

Class IITerminated

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 Health: 55910-011-01; NDC Kirkland: 63981-852-56; NDC Kroger: 30142-600-56; NDC Meijer: 41250-852-01; NDC Rite Aid: 11822-0852-4; NDC Walgreens: 0363-0852-01

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

October 23, 2019 · DrugView details →

Class IITerminated

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

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

October 23, 2019 · DrugView details →

Class IITerminated

Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Made in Australia, NDC 0378-4003-05

Mylan Pharmaceuticals Inc.

Presence of Foreign Substance

October 23, 2019 · DrugView details →

Class IITerminated

Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-800-75; NDC Up & Up: 11673-950-75

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

October 23, 2019 · DrugView details →

Class IITerminated

Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 62011-0283-2; NDC Major: 0904-6715-52; NDC Meijer: 41250-252-72; NDC Sunmark: 49348-136-12;

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

October 23, 2019 · DrugView details →

Class ITerminated

Green Lumber Natural Fuel For Men capsule, packaged in packs of 2, 4 and 10 capsules, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660 (949) 426-8622.

Green Lumber Holdings, LLC

Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.

October 22, 2019 · DrugView details →

Class IIOngoing

Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0120-06, 0597-0120-08, 0597-0120-09, 0597-0120-24, 0597-0120-38, 0597-0120-50, 0597-0120-76, 0597-0120-78, 0597-0120-80, 0597-0120-82, 0597-0120-87.

Sanofi-Aventis U.S. LLC

CGMP Deviations: Presence of NDMA impurity detected in product.

October 22, 2019 · DrugView details →

Class IIOngoing

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 50269-222-25.

Sanofi-Aventis U.S. LLC

CGMP Deviations: Presence of NDMA impurity detected in product.

October 22, 2019 · DrugView details →

Class IIOngoing

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 67751-152-01 67751-152-02

Sanofi-Aventis U.S. LLC

CGMP Deviations: Presence of NDMA impurity detected in product.

October 22, 2019 · DrugView details →

Class IIOngoing

Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 66715-9736-2 66715-9736-3 66715-9736-8

Sanofi-Aventis U.S. LLC

CGMP Deviations: Presence of NDMA impurity detected in product.

October 22, 2019 · DrugView details →

Class IITerminated

Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-88), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India; Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430.

Glenmark Pharmaceuticals Inc., USA

Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.

October 22, 2019 · DrugView details →

Class IIOngoing

Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's 41167-0300-0, 41167-0300-1, 41167-0300-3, 41167-0300-5, 41167-0300-6, 41167-0300-7, 41167-0300-8

Sanofi-Aventis U.S. LLC

CGMP Deviations: Presence of NDMA impurity detected in product.

October 22, 2019 · DrugView details →

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