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Recall Observatory FDA recall evidence

Drug product

Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-159-30

D-0285-2022

December 01, 2021

Class III

Product summary

Firm
Torrent Pharma Inc.
Event
Event 89141
Status
Terminated
Classification
Class III
Quantity
27,312 Bottles
Official record key
drug-enforcement:D-0285-2022

Official wording

Reason: Superpotent; Hydrochlorothiazide

Code information: Batch: BZ74G001 Exp. 12/2021.

Distribution pattern: Nationwide USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent