Recalls / Class II
Class IID-1177-2018
Product
AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-888-90
- Affected lot / code info
- Lots: 17308 Exp. 09/2018; 18158 Exp. 09/2018; 18539 Exp. 01/2019; 19021 Exp. 01/2019; 19225 Exp. 01/2019; 20033 Exp. 06/2019; 20290 Exp. 06/2019; 20565 Exp. 06/2019; 21369 Exp. 10/2019
Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recalling firm
- Firm
- Avkare Incorporated
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 114 S 1st St, N/A, Pulaski, Tennessee 38478-3216
Distribution
- Quantity
- 19623 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-07-18
- FDA classified
- 2018-09-06
- Posted by FDA
- 2018-09-12
- Terminated
- 2020-05-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1177-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.