Recalls / Class II
Class IID-1175-2018
Product
AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-887-90
- Affected lot / code info
- Lots: 17325 Exp. 09/2018; 17856 Exp. 09/2018; 18396 Exp. 09/2018; 18702 Exp. 02/2019; 19020 Exp. 02/2019; 19222 Exp. 02/2019; 20030 Exp. 04/2019; 20381 Exp. 04/2019
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
- 19109 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-1175-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.