D-1264-2019 Class II Ongoing
FDA drug recall D-1264-2019 was initiated by Torrent Pharma Inc. on April 18, 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. The recall status is ongoing. Affected quantity: 28,464 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 8, 2019
- Initiation Date
- April 18, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28,464 bottles
Product Description
Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)1000-count (NDC: 13668-113-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
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.
Distribution Pattern
Nationwide USA and Puerto Rico
Code Information
Count, lots, expiry: [90-count bottle] Lot BDK1C003, exp 07/31/2019; [1000-count bottle] Lot BDK1C002, exp 07/31/2019; Lots 4DU1D004, 4DU1D005, 4DU1D006, exp 12/31/2019