Recalls / Class II
Class IID-1046-2019
Product
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15
- Affected lot / code info
- Lot: 19326 Exp. 03/31/2019
Why it was recalled
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
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
- N/A
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2019-03-05
- FDA classified
- 2019-03-21
- Posted by FDA
- 2019-03-27
- Terminated
- 2020-12-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1046-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.