D-0503-2019 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- February 27, 2019
- Initiation Date
- December 20, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43,416 bottles
Product Description
LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
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 Pattern
Nationwide USA and Puerto Rico
Code Information
Count, lots, expiry: [90-count bottle] Lot 4O49C013, exp 09/2019