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Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limite...

FDA Recall #D-0388-2024 — Class II — February 9, 2024

Recall #D-0388-2024 Date: February 9, 2024 Classification: Class II Status: Terminated

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.

Reason for Recall

Failed Stability Specifications: Out of specification for blend uniformity.

Recalling Firm

Micro Labs Limited — Verna, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

118,080 bottles

Distribution

Puerto Rico, TN, RI

Code Information

Lot #s: SFBG024, SFBG025, Exp. 05/31/2024

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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