Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131
Reported: January 29, 2020 Initiated: December 20, 2019 #D-0795-2020
Product Description
Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131
Reason for Recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Details
- Recalling Firm
- Denton Pharma, Inc.
- Units Affected
- 467 bottles
- Distribution
- Nationwide
- Location
- North Blenheim, NY
Frequently Asked Questions
What product was recalled? ▼
Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131. Recalled by Denton Pharma, Inc.. Units affected: 467 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 January 29, 2020. Severity: Moderate. Recall number: D-0795-2020.
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