Recalls / Class III
Class IIID-0285-2022
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
- Affected lot / code info
- Batch: BZ74G001 Exp. 12/2021.
Why it was recalled
Superpotent; Hydrochlorothiazide
Recalling firm
- Firm
- Torrent Pharma Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 150 Allen Rd Ste 102, Basking Ridge, New Jersey 07920-3856
Distribution
- Quantity
- 27,312 Bottles
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2021-12-01
- FDA classified
- 2021-12-16
- Posted by FDA
- 2021-12-22
- Terminated
- 2024-05-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0285-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.