Recalls / Class II

Class IID-1119-2019

Product

Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, a) 30-count (NDC: 13668-118-30), b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10) 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

Affected lot / code info

Count, lots, expiry: [30-count bottle] Lot BEF6D038, exp 4/30/2020; [90-count bottle] Lots BEF6D030, BEF6D031, exp 4/30/2020; Lots BEF6D047, BEF6D048, BEF6D049, BEF6D050, BEF6D051, exp 7/31/2020; Lots BEF6D082, BEF6D083, BEF6D084, BEF6D085, BEF6D086, BEF6D087, exp 10/31/2020; Lots 4P04E003, 4P04E004, 4P04E005, 4P04E006, exp 1/31/2021; [1000-count bottle] 4P04E007, 4P04E008, 4P04E009, exp 1/31/2021

Why it was recalled

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

Recalling firm

Firm

Torrent Pharma Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

150 Allen Rd Ste 102, N/A, Basking Ridge, New Jersey 07920-3856

Distribution

Quantity

173,760 bottles

Distribution pattern

Nationwide USA and Puerto Rico

Timeline

Recall initiated

2019-02-28

FDA classified

2019-04-10

Posted by FDA

2019-04-17

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-1119-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.