Recalls / Class II
Class IID-1341-2020
Product
Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA, NDC 62332-097-30.
- Brand name
- Aripiprazole
- Generic name
- Aripiprazole
- Active ingredient
- Aripiprazole
- Route
- Oral
- NDCs
- 62332-097, 62332-098, 62332-099, 62332-100, 62332-101, 62332-102
- FDA application
- ANDA202101
- Affected lot / code info
- Lot: 1905003298 Exp. 01/31/2021
Why it was recalled
Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
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
- 19,153 bottles
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2020-06-10
- FDA classified
- 2020-06-24
- Posted by FDA
- 2020-07-01
- Terminated
- 2022-01-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1341-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.