Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals
Reported: December 18, 2019 Initiated: December 2, 2019 #D-0617-2020
Product Description
Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Details
- Recalling Firm
- Preferred Pharmaceuticals, Inc
- Units Affected
- 316 bottles
- Distribution
- CA, FL
- Location
- Anaheim, CA
Frequently Asked Questions
What product was recalled? ▼
Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals. Recalled by Preferred Pharmaceuticals, Inc. Units affected: 316 bottles.
Why was this product recalled? ▼
CGMP Deviations: Presence of NDMA impurity detected in product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 18, 2019. Severity: Moderate. Recall number: D-0617-2020.
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