PlainRecalls
FDA Drug Critical Class I Terminated

Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807, NDC 62332-087-30

Reported: April 14, 2021 Initiated: March 17, 2021 #D-0326-2021

Product Description

Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807, NDC 62332-087-30

Reason for Recall

Labeling: Label-mixup

Details

Units Affected
12288 bottles
Distribution
Nationwide within the United States
Location
Tajpura, N/A

Frequently Asked Questions

What product was recalled?
Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807, NDC 62332-087-30. Recalled by Alembic Pharmaceuticals Limited. Units affected: 12288 bottles.
Why was this product recalled?
Labeling: Label-mixup
Which agency issued this recall?
This recall was issued by the FDA Drug on April 14, 2021. Severity: Critical. Recall number: D-0326-2021.