Why it was recalled
Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot: 1905003298 Exp. 01/31/2021
Where it was sold
Nationwide in the U.S.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1341-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 10, 2020
- FDA report date
- Jul 1, 2020
- Quantity
- 19,153 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alembic Pharmaceuticals Limited
Original FDA data
Every field from FDA enforcement report D-1341-2020, exactly as published.
Show all FDA fields
- City
- Tajpura
- Status
- Terminated
- Country
- India
- Event ID
- 85835
- Address
- Near Baska
- Code information
- Lot: 1905003298 Exp. 01/31/2021
- Report date
- Jul 1, 2020
- Product type
- Drugs
- Recall number
- D-1341-2020
- Classification
- Class II
- Recalling firm
- Alembic Pharmaceuticals Limited
- Product quantity
- 19,153 bottles
- Termination date
- Jan 19, 2022
- Reason for recall
- Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Jun 10, 2020
- Initial firm notification
- Letter
- Center classification date
- Jun 24, 2020