FDA-Drug2021-04-14Class I

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

Alembic Pharmaceuticals Limited
Hazard

Labeling: Label-mixup

Sold states
Nationwide within the United States
Affected count
12288 bottles
Manufactured in
Near Baska, N/A, Tajpura, N/A, India
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0326-2021

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