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Heartburn & Stomach Medication Recalls

Recalls of acid reducers and stomach drugs - the class behind the ranitidine (Zantac) nitrosamine recalls.

209 recalls in this category, newest first.

Class II · Moderate risk Terminated Oct 23, 2019

Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Being Well: 46994-852-62…

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

Perrigo Company PLC D-1018-2020

Class II · Moderate risk Terminated Oct 23, 2019

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

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

Perrigo Company PLC D-1017-2020

Class II · Moderate risk Terminated Oct 23, 2019

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

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

Perrigo Company PLC D-1016-2020

Class II · Moderate risk Terminated Oct 23, 2019

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

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

Perrigo Company PLC D-1015-2020

Class II · Moderate risk Terminated Oct 23, 2019

Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets per bottle. [NDC: Brand] NDC Basic Care: 0113-7876-27…

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

Perrigo Company PLC D-1014-2020

Class II · Moderate risk Terminated Oct 23, 2019

Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 62011-0283-2…

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

Perrigo Company PLC D-1013-2020

Class II · Moderate risk Terminated Oct 23, 2019

Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle. [NDC: Brand] NDC CVS Health: 69842-293-65…

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

Perrigo Company PLC D-1012-2020

Class II · Moderate risk Terminated Oct 17, 2019

AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE…

Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

AVKARE Inc. NDC 42291-736-50 D-0165-2020

Class II · Moderate risk Terminated Oct 17, 2019

AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE…

Reason CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

AVKARE Inc. NDC 42291-735-50 D-0164-2020

Class II · Moderate risk Completed Oct 1, 2019

Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. D-0185-2020

Class II · Moderate risk Completed Oct 1, 2019

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) 50-count bottles (NDC 63868-480-50) (CDMA) OTC

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. NDC 63868-480-24 D-0184-2020

Class II · Moderate risk Completed Oct 1, 2019

Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) OTC

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. NDC 0363-0131-30 D-0183-2020

Class II · Moderate risk Completed Oct 1, 2019

Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC)

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. NDC 55111-404-34 D-0182-2020

Class II · Moderate risk Completed Oct 1, 2019

Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC)

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. NDC 55111-131-60 D-0181-2020

Class II · Moderate risk Completed Oct 1, 2019

Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.) 100 count bottles (NDC 55111-130-01)

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. NDC 55111-130-30 D-0180-2020

Class II · Moderate risk Completed Oct 1, 2019

Ranitidine Tablets, USP 150 mg, 40 count bottles, NDC 11673-849-40 (Target) OTC.

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. NDC 11673-849-40 D-0179-2020

Class II · Moderate risk Completed Oct 1, 2019

Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC.

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. D-0178-2020

Class II · Moderate risk Completed Oct 1, 2019

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 71713-203-02), b.)95 count bottles (NDC 71713-203-05) (Thirty Madison)…

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. NDC 71713-203-02 D-0177-2020

Class II · Moderate risk Completed Oct 1, 2019

Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) 220 count bottles (NDC 43598-808-65) (HCA) OTC.

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. NDC 43598-808-62 D-0176-2020

Class II · Moderate risk Completed Oct 1, 2019

Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. NDC 63868-482-30 D-0175-2020

Class II · Moderate risk Completed Oct 1, 2019

Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger)

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. NDC 30142-131-30 D-0174-2020

Class II · Moderate risk Completed Oct 1, 2019

Ranitidine Tablets, USP 75 mg, a.) 30 count bottles (NDC 69842-871-30) b.) 80 count bottles (NDC 69842-871-80) c.)160 count…

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. NDC 69842-871-30 D-0173-2020

Class II · Moderate risk Completed Oct 1, 2019

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 30142-505-34), b.) 50 count bottles (NDC 30142-505-50) (Kroger) OTC

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. NDC 30142-505-34 D-0172-2020

Class II · Moderate risk Completed Oct 1, 2019

Ranitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 130 count bottles (NDC 49035-404-13) c.) 220 count…

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. NDC 49035-404-61 D-0171-2020

Class II · Moderate risk Completed Oct 1, 2019

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 0363-0010-34), b.) 65 count bottles (NDC 0363-0010-61) , c.) 95 count…

Reason CGMP Deviations: Presence of NDMA impurity detected in product.

Dr. Reddy's Laboratories, Inc. NDC 0363-0010-34 D-0170-2020