Drug & medication recalls Moderate risk

Micro Labs Limited recalls Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA,…

Recall date
February 9, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0388-2024
FDA classification
Class II
Brand / firm
Micro Labs Limited
Sold / distributed
Puerto Rico, TN, RI

Why it was recalled

Failed Stability Specifications: Out of specification for blend uniformity.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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