Recalls / Class II

Class IID-1268-2019

Product

Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC: 13668-117-90), b) 1000-count (NDC: 13668-117-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India

Affected lot / code info

Count, lots, expiry: [90-count bottle] Lot BX35D024, exp 1/31/2020; BEF8D060, BEF8D061, BEF8D062, BEF8D063, BEF8D064, exp 11/30/2020; [1000-count bottle] Lot BEF8D059, exp 11/30/2020; Lots BEF8E004, BEF8E005, 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

Press Release

Type

Voluntary: Firm initiated

Address

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

Distribution

Quantity

54,084 bottles

Distribution pattern

Nationwide USA and Puerto Rico

Timeline

Recall initiated

2019-04-18

FDA classified

2019-05-01

Posted by FDA

2019-05-08

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-1268-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.