D-1281-2019 Class II Terminated
FDA drug recall D-1281-2019 was initiated by Preferred Pharmaceuticals, Inc on April 30, 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 at the manufacturer The recall status is terminated (terminated April 3, 2023).
Recall Details
- Product Type
- Drugs
- Report Date
- May 22, 2019
- Initiation Date
- April 30, 2019
- Termination Date
- April 3, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ
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 at the manufacturer
Distribution Pattern
CA, GA, IN. No DOD/VA accounts. No foreign accounts.
Code Information
a) 30 tablets: lot A1818G batch 01181807 exp 3/2020; b) 90 tablets: lot L0517L batch 12051712 exp 3/2020