Home / Recalls / Torrent Pharma Inc. / D-0501-2019

D-0501-2019 Class II Ongoing

Recalled by Torrent Pharma Inc. — Kalamazoo, MI

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
83,016 bottles

Product Description

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

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: [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

Other recalls by Torrent Pharma Inc.

  • D-0456-2025 Class II — Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by (May 27, 2025)
  • D-0455-2025 Class II — Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORR (May 27, 2025)
  • D-0852-2022 Class II — Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per (April 11, 2022)
  • D-0365-2022 Class II — Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactu (December 2, 2021)
  • D-0285-2022 Class III — Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottle (December 1, 2021)
  • D-0166-2021 Class I — Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: (November 25, 2020)
  • D-1317-2020 Class II — Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manu (May 11, 2020)
  • D-0123-2020 Class II — Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per (September 19, 2019)
  • D-0122-2020 Class II — Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only (September 19, 2019)
  • D-0121-2020 Class II — Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufact (September 19, 2019)