Home / Recalls / Torrent Pharma Inc. / D-1144-2018

D-1144-2018 Class II Ongoing

Recalled by Torrent Pharma Inc. — Basking Ridge, NJ

Recall Details

Product Type: Drugs
Report Date: September 5, 2018
Initiation Date: August 17, 2018
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 34320 bottles

Product Description

Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-328-30

Reason for Recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Distribution Pattern

Nationwide USA

Code Information

Batch: BBX9D004, BBX9E001, BBX9D001, BBX9D002, BBX9D003

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)