Class II
Ongoing
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
- Company
- Torrent Pharma Inc.
- Recall Initiated
- April 18, 2019
- Posted
- May 8, 2019
- Recall Number
- D-1264-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 28,464 bottles
- Firm Location
- Basking Ridge, NJ, United States
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
Nationwide USA and Puerto Rico
Lot / Code Info
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
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