Recalls / Class II
Class IID-1130-2018
Product
Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478
- Affected lot / code info
- Lots: 18491 Exp. 10/2018; 19531 Exp. 04/2019; 20168 Exp. 05/2019; 20671 Exp. 08/2019; 21049 Exp. 10/2019; 21635 Exp. 10/2019
Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recalling firm
- Firm
- AVKARE Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 615 N 1st St, N/A, Pulaski, Tennessee 38478-2403
Distribution
- Quantity
- 6776 cartons (338,800 tablets)
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2018-08-14
- FDA classified
- 2018-08-28
- Posted by FDA
- 2018-09-05
- Terminated
- 2020-05-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1130-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.