Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Reported: September 5, 2018 Initiated: August 14, 2018 #D-1131-2018
Product Description
Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Details
- Recalling Firm
- AVKARE Inc.
- Units Affected
- 728 cartons (36,400 tablets)
- Distribution
- U.S. Nationwide
- Location
- Pulaski, TN
Frequently Asked Questions
What product was recalled? ▼
Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478. Recalled by AVKARE Inc.. Units affected: 728 cartons (36,400 tablets).
Why was this product recalled? ▼
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 5, 2018. Severity: Moderate. Recall number: D-1131-2018.
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