Class II
Ongoing
Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
This recall is currently active, issued May 8, 2019. It was issued by Avkare Inc..
- Company
- Avkare Inc.
- Recall Initiated
- April 24, 2019
- Posted
- May 8, 2019
- Recall Number
- D-1249-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1438 cartons (71,900 tablets)
- Firm Location
- Pulaski, TN, United States
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide
Lot / Code Info
Lot: 20121 Exp. 6/30/2019
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