Drug Enforcement D-0388-2024

Failed Stability Specifications: Out of specification for blend uniformity.

Status

Terminated

Classification

Class II

Report Date

March 20, 2024

Termination Date

June 24, 2025

Product Information

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.
Product quantity
118,080 bottles
Reason for recall
Failed Stability Specifications: Out of specification for blend uniformity.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Puerto Rico, TN, RI

Location & Firm

Recalling firm
Micro Labs Limited
Address
Plot# S - 155, & N1 Phase Iii & Phase Iv; Verna Ind Estate Road

India
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0388-2024
Event ID
93965
Recall initiation date
February 9, 2024
Center classification date
March 14, 2024
Code info
Lot #s: SFBG024, SFBG025, Exp. 05/31/2024
More code info
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