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 Jan 7, 2020

Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.

Reason CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.

Mylan Pharmaceuticals Inc. NDC 0378-5300-93 D-0792-2020

Class II · Moderate risk Terminated Jan 7, 2020

Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.

Reason CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.

Mylan Pharmaceuticals Inc. NDC 0378-5150-91 D-0791-2020

Class II · Moderate risk Terminated Jan 7, 2020

Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only…

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

Appco Pharma LLC NDC 62559-690-60 D-0649-2020

Class II · Moderate risk Terminated Jan 7, 2020

Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by…

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

Appco Pharma LLC NDC 62559-691-30 D-0648-2020

Class II · Moderate risk Terminated Jan 6, 2020

Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc…

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

H J Harkins Company Inc dba Pharma Pac D-0793-2020

Class II · Moderate risk Terminated Dec 26, 2019

Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.

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

AAA Pharmaceutical, Inc. NDC 37808-196-04 D-0646-2020

Class II · Moderate risk Terminated Dec 26, 2019

Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.

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

AAA Pharmaceutical, Inc. NDC 37808-196-01 D-0645-2020

Class II · Moderate risk Terminated Dec 20, 2019

Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only…

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

Denton Pharma, Inc. NDC 70934-287-15 D-0795-2020

Class II · Moderate risk Terminated Dec 20, 2019

Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count…

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

Denton Pharma, Inc. NDC 70934-017-04 D-0794-2020

Class II · Moderate risk Ongoing Dec 17, 2019

Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa…

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

Glenmark Pharmaceuticals Inc., USA NDC 68462-248-05 D-0644-2020

Class II · Moderate risk Ongoing Dec 17, 2019

Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa…

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

Glenmark Pharmaceuticals Inc., USA NDC 68462-249-20 D-0643-2020

Class II · Moderate risk Ongoing Dec 17, 2019

Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa…

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

Glenmark Pharmaceuticals Inc., USA NDC 68462-249-01 D-0642-2020

Class II · Moderate risk Ongoing Dec 17, 2019

Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa…

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

Glenmark Pharmaceuticals Inc., USA NDC 68462-249-30 D-0641-2020

Class II · Moderate risk Ongoing Dec 17, 2019

Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa…

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

Glenmark Pharmaceuticals Inc., USA NDC 68462-248-01 D-0640-2020

Class II · Moderate risk Ongoing Dec 17, 2019

Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa…

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

Glenmark Pharmaceuticals Inc., USA NDC 68462-248-60 D-0639-2020

Class II · Moderate risk Ongoing Dec 13, 2019

RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32

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

Granules India Limited NDC 62207-773-32 D-0632-2020

Class II · Moderate risk Terminated Dec 11, 2019

Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00

Reason CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.

RemedyRepack Inc. NDC 65162-0253-10 D-0798-2020

Class II · Moderate risk Terminated Dec 2, 2019

Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg…

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

Preferred Pharmaceuticals, Inc NDC 68788-7078-03 D-0617-2020

Class II · Moderate risk Ongoing Nov 22, 2019

Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.

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

Amneal Pharmaceuticals, Inc. NDC 53746-254-02 D-0616-2020

Class II · Moderate risk Ongoing Nov 22, 2019

Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.

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

Amneal Pharmaceuticals, Inc. NDC 53746-253-10 D-0615-2020

Class II · Moderate risk Ongoing Nov 22, 2019

Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.

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

Amneal Pharmaceuticals, Inc. NDC 65162-664-90 D-0614-2020

Class II · Moderate risk Ongoing Nov 22, 2019

Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c)…

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

Amneal Pharmaceuticals, Inc. NDC 65162-254-30 D-0613-2020

Class II · Moderate risk Ongoing Nov 22, 2019

Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count…

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

Amneal Pharmaceuticals, Inc. NDC 65162-253-06 D-0612-2020

Class II · Moderate risk Terminated Nov 20, 2019

Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American…

Reason CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

American Health Packaging D-1003-2020

Class II · Moderate risk Terminated Nov 14, 2019

AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC…

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

AVKARE Inc. NDC 42291-725-25 D-0525-2020

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