Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
Reported: January 15, 2020 Initiated: December 26, 2019 #D-0645-2020
Product Description
Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
Reason for Recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Details
- Recalling Firm
- AAA Pharmaceutical, Inc.
- Units Affected
- 34,272 (24-count bottles)
- Distribution
- Product was distributed to one consignee who may have distributed the product further to their retail stores.
- Location
- Lumberton, NJ
Frequently Asked Questions
What product was recalled? ▼
Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.. Recalled by AAA Pharmaceutical, Inc.. Units affected: 34,272 (24-count bottles).
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 15, 2020. Severity: Moderate. Recall number: D-0645-2020.
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