Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131.
Reported: January 29, 2020 Initiated: December 20, 2019 #D-0794-2020
Product Description
Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), 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
- 1,341 bottles
- Distribution
- Nationwide
- Location
- North Blenheim, NY
Frequently Asked Questions
What product was recalled? ▼
Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131.. Recalled by Denton Pharma, Inc.. Units affected: 1,341 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-0794-2020.
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