RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
Reported: January 8, 2020 Initiated: December 13, 2019 #D-0632-2020
Product Description
RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
Reason for Recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Details
- Recalling Firm
- Granules India Limited
- Units Affected
- 23,090,000 tablets
- Distribution
- OR, NY, NJ
- Location
- Qutbullapur Mandal, Ranga Redd, N/A
Frequently Asked Questions
What product was recalled? ▼
RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32. Recalled by Granules India Limited. Units affected: 23,090,000 tablets.
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 January 8, 2020. Severity: Moderate. Recall number: D-0632-2020.
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