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.
Reported: March 20, 2024 Initiated: February 9, 2024 #D-0388-2024
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.
Details
- Recalling Firm
- Micro Labs Limited
- Units Affected
- 118,080 bottles
- Distribution
- Puerto Rico, TN, RI
- Location
- Verna, N/A
Frequently Asked Questions
What product 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.. Recalled by Micro Labs Limited. Units affected: 118,080 bottles.
Why was this product recalled? ▼
Failed Stability Specifications: Out of specification for blend uniformity.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 20, 2024. Severity: Moderate. Recall number: D-0388-2024.
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