FDA-Drug2024-03-20Class II
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.
Micro Labs Limited
Hazard
Failed Stability Specifications: Out of specification for blend uniformity.
Sold states
Puerto Rico, TN, RI
Affected count
118,080 bottles
Manufactured in
Plot# S - 155, & N1 Phase Iii & Phase Iv; Verna Ind Estate Road, Verna, N/A, India
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0388-2024Don't want to check this manually?
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