FDA recall D-0326-2021

Product

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

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2021-03-17

Report date

2021-04-14

Termination date

2022-12-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tajpura, N/A, India

Primary source

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