D-0124-2020 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- October 9, 2019
- Initiation Date
- September 19, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,688 bottles
Product Description
Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-118-90
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 9.82 parts per million.
Distribution Pattern
Nationwide USA and Puerto Rico
Code Information
Lot 4P04D007