FDAFDA · Food and drugs·Recall number D-1341-2020
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.
Published July 1, 2020 · Recall initiated: June 10, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ARIPIPRAZOLE
- Manufacturer
- Alembic Pharmaceuticals Limited
- Distributor
- Nationwide in the U.S.
- UPC
- 0362332097302
- Lot
- Lot: 1905003298 Exp. 01/31/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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