Class II
Ongoing
LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count (NDC: 13668-115-90), c) 1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
This recall is currently active, issued February 27, 2019. It was issued by Torrent Pharma Inc..
- Company
- Torrent Pharma Inc.
- Recall Initiated
- December 20, 2018
- Posted
- February 27, 2019
- Recall Number
- D-0501-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 83,016 bottles
- Firm Location
- Kalamazoo, MI, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Distribution
Nationwide USA and Puerto Rico
Lot / Code Info
Count, lots, expiry: [30-count bottle] Lot BO31C016, exp 04/2019; [90-count bottle] Lot BO31C016, exp 04/2019; [1000-count bottle] Lots 4DK3C004, 4DK3C005, exp 04/2019; Lots 4DU3C040, exp 10/2019; Lots 4DU3E049, 4DU3E050, exp 05/2021
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