Recalls / Class II
Class IID-1250-2019
Product
Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
- Affected lot / code info
- Lot: 19554 Exp. 4/30/2019
Why it was recalled
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
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
- 846 cartons (42,300 tablets)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2019-04-24
- FDA classified
- 2019-04-28
- Posted by FDA
- 2019-05-08
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-1250-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.