Class II · Moderate risk Ongoing
Aripiprazole Tablets USP
Reason Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Aripiprazole Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
What was recalled
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.
- Recalling firm
- Alembic Pharmaceuticals Limited
- NDC code
- 62332-097-30
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1341-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Aripiprazole recalls
See all
Class II · Moderate risk Ongoing
Aripiprazole Tablets
Reason Superpotent drug
Class III · Low risk Ongoing
Abilify
Reason Cross Contamination with Other Products
Class III · Low risk Ongoing
Abilify
Reason Cross Contamination with Other Products
Class III · Low risk Ongoing
Abilify
Reason Cross Contamination with Other Products
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