Recalls / Class II
Class IID-1176-2018
Product
AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-886-90
- Affected lot / code info
- Lots: 17780 Exp. 09/2018; 18029 Exp. 09/2018; 18398 Exp. 09/2018; 18723 Exp. 09/2018; 19017 Exp. 02/2019; 19224 Exp. 02/2019; 20032 Exp. 08/2019; 20289 Exp. 08/2019; 21076 Exp. 08/2019; 21382 Exp. 08/2019
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
- 12950 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-1176-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.