FDAFDA · Food and drugs·Recall number D-0388-2024
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.
Published March 20, 2024 · Recall initiated: February 9, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications: Out of specification for blend uniformity.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Micro Labs Limited
- Distributor
- Puerto Rico, TN, RI
- Lot
- Lot #s: SFBG024, SFBG025, Exp. 05/31/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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