Recalls / Class I
Class ID-0326-2021
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Brand name
- Telmisartan
- Generic name
- Telmisartan
- Active ingredient
- Telmisartan
- Route
- Oral
- NDCs
- 62332-087, 62332-088, 62332-089
- FDA application
- ANDA202130
- Affected lot / code info
- Lot #: 1905005661, Exp March 2022
Why it was recalled
Labeling: Label-mixup
Recalling firm
- Firm
- Alembic Pharmaceuticals Limited
- Manufacturer
- Alembic Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Near Baska, N/A, Tajpura, N/A N/A, India
Distribution
- Quantity
- 12288 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-03-17
- FDA classified
- 2021-04-07
- Posted by FDA
- 2021-04-14
- Terminated
- 2022-12-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0326-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.