D-1270-2019 Class II Terminated
FDA drug recall D-1270-2019 was initiated by RemedyRepack Inc. on April 22, 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 terminated (terminated May 19, 2020). Affected quantity: 44 HDPE bottles of 90 = 3,960 tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- May 8, 2019
- Initiation Date
- April 22, 2019
- Termination Date
- May 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44 HDPE bottles of 90 = 3,960 tablets
Product Description
Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc. Indiana, PA, 15701-3570, NDC 70518-1560-00.
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
Product was distributed to Florida.
Code Information
Lot #: B0517068-101618, Exp. Date: 10/2019