Recalls / Class II

Class IID-0501-2019

Product

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

Affected 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

Why it was recalled

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.

Recalling firm

Firm

Torrent Pharma Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1803 Whites Rd Ste 1, Kalamazoo, Michigan 49008-2883

Distribution

Quantity

83,016 bottles

Distribution pattern

Nationwide USA and Puerto Rico

Timeline

Recall initiated

2018-12-20

FDA classified

2019-02-15

Posted by FDA

2019-02-27

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0501-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.