Why it was recalled
Failed Stability Specifications: Out of specification for blend uniformity.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #s: SFBG024, SFBG025, Exp. 05/31/2024
Where it was sold
Puerto Rico, TN, RI
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0388-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 9, 2024
- FDA report date
- Mar 20, 2024
- Quantity
- 118,080 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Micro Labs Limited
Original FDA data
Every field from FDA enforcement report D-0388-2024, exactly as published.
Show all FDA fields
- City
- Verna
- Status
- Terminated
- Country
- India
- Event ID
- 93965
- Address
- Plot# S - 155
- Address (line 2)
- & N1 Phase Iii & Phase Iv; Verna Ind Estate Road
- Code information
- Lot #s: SFBG024, SFBG025, Exp. 05/31/2024
- Report date
- Mar 20, 2024
- Product type
- Drugs
- Recall number
- D-0388-2024
- Classification
- Class II
- Recalling firm
- Micro Labs Limited
- Product quantity
- 118,080 bottles
- Termination date
- Jun 24, 2025
- Reason for recall
- Failed Stability Specifications: Out of specification for blend uniformity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Puerto Rico, TN, RI
- Recall initiation date
- Feb 9, 2024
- Initial firm notification
- Letter
- Center classification date
- Mar 14, 2024