D-1046-2019 Class II Terminated
FDA drug recall D-1046-2019 was initiated by AVKARE Inc. on March 5, 2019 and is designated Class II. Reason for recall: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified The recall status is terminated (terminated December 7, 2020). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- March 27, 2019
- Initiation Date
- March 5, 2019
- Termination Date
- December 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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
Reason for Recall
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Distribution Pattern
Nationwide.
Code Information
Lot: 19326 Exp. 03/31/2019