Recalls / Class II
Class IID-0388-2024
Product
Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873, NDC 42571-227-30.
- Brand name
- Telmisartan
- Generic name
- Telmisartan
- Active ingredient
- Telmisartan
- Route
- Oral
- NDCs
- 42571-226, 42571-227, 42571-228
- FDA application
- ANDA207016
- Affected lot / code info
- Lot #s: SFBG024, SFBG025, Exp. 05/31/2024
Why it was recalled
Failed Stability Specifications: Out of specification for blend uniformity.
Recalling firm
- Firm
- Micro Labs Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Plot# S - 155, & N1 Phase Iii & Phase Iv; Verna Ind Estate Road, Verna, N/A N/A, India
Distribution
- Quantity
- 118,080 bottles
- Distribution pattern
- Puerto Rico, TN, RI
Timeline
- Recall initiated
- 2024-02-09
- FDA classified
- 2024-03-14
- Posted by FDA
- 2024-03-20
- Terminated
- 2025-06-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0388-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.