Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ

Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

Code information: Count, lots, expiry: [30-count bottle] Lot BEF7D017,exp 6/30/2020 [90-count bottle] Lots BEF7D010, BEF7D011, exp 4/30/2020; Lot BEF7D018, exp 6/30/2020; Lot BEF7D009, exp 4/30/2020; Lots 4P02E002, 4P02E003, 4P02E004, exp 1/31/2021; [1000-count bottle] Lots BEF7D008, BEF7D012, BEF7D013, exp 4/30/2020; Lot BEF7D022, exp 8/31/2020; Lot BEF7D049, exp 11/30/2020; Lots 4P02E005, 4P02E006, exp 1/31/2021

Distribution pattern: Nationwide USA and Puerto Rico