Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, M
Summary
The FDA issued a Class II for Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: by Micro Labs Limited. Reason: Failed Stability Specifications: Out of specification for blend uniformity..
Details
Source
Drug Recall
External ID
D-0388-2024
Action Date
2024-03-20
Status
Terminated
Category
drug
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.
Lot/Code Info: Lot #s: SFBG024, SFBG025, Exp. 05/31/2024
Quantity Affected: 118,080 bottles
Reason for Recall
Failed Stability Specifications: Out of specification for blend uniformity.
Distribution
Puerto Rico, TN, RI
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-09
Company
Verna, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 46 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Micro Labs Limited has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Micro Labs Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Micro Labs Limited have FDA actions?
Micro Labs Limited has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0388-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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