D-0032-2021 Class II Terminated
FDA drug recall D-0032-2021 was initiated by Direct Rx on March 12, 2019 and is designated Class II. Reason for recall: CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API. The recall status is terminated (terminated September 21, 2021). Affected quantity: 33 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 7, 2020
- Initiation Date
- March 12, 2019
- Termination Date
- September 21, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33 bottles
Product Description
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90
Reason for Recall
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
Distribution Pattern
FL
Code Information
Lot: 12DE1806 Exp. 01/31/2021