D-1250-2019 Class II Ongoing
FDA drug recall D-1250-2019 was initiated by AVKARE Inc. on April 24, 2019 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 846 cartons (42,300 tablets).
Recall Details
- Product Type
- Drugs
- Report Date
- May 8, 2019
- Initiation Date
- April 24, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 846 cartons (42,300 tablets)
Product Description
Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
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 Pattern
Nationwide
Code Information
Lot: 19554 Exp. 4/30/2019