FDA Recall D-0326-2021
Alembic Pharmaceuticals Limited · Tajpura, N/A
Class I — life-threatening Terminated 628 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Recall record
- Recall number
D-0326-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the United States
- Recall initiated
- 2021-03-17
- Classified by FDA Center
- 2021-04-07
- FDA published
- 2021-04-14
- Terminated
- 2022-12-05
- Recalling firm
- Alembic Pharmaceuticals Limited
- Firm location
- Tajpura, N/A, India
Drug identification
- Brand name(s)
- TELMISARTAN
- Generic name(s)
- TELMISARTAN
- Manufacturer(s)
- Alembic Pharmaceuticals Inc.
- NDC(s)
62332-087, 62332-088, 62332-089- Route(s)
- ORAL