Class II · Moderate risk
Preferred Pharmaceuticals
CGMP Deviations: Presence of NDMA impurity detected in product.
Heartburn & Stomach Medication Recalls
Recalls of acid reducers and stomach drugs - the class behind the ranitidine (Zantac) nitrosamine recalls.
211 recalls in this category, newest first.
Class II · Moderate risk
Preferred Pharmaceuticals
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Nizatidine Capsules
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Class II · Moderate risk
Nizatidine Capsules
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Class II · Moderate risk
Ranitidine Capsules 150 mg
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine Capsules 300 mg
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine 150 mg tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine 150 mg tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10…
CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
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