Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).
Reported: December 18, 2019 Initiated: November 22, 2019 #D-0613-2020
Product Description
Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).
Reason for Recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Details
- Recalling Firm
- Amneal Pharmaceuticals, Inc.
- Units Affected
- N/A
- Distribution
- Product was distributed throughout the United States.
- Location
- Brookhaven, NY
Frequently Asked Questions
What product was recalled? ▼
Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).. Recalled by Amneal Pharmaceuticals, Inc.. Units affected: N/A.
Why was this product recalled? ▼
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 18, 2019. Severity: Moderate. Recall number: D-0613-2020.
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