Drug product
Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03.
D-0594-2026
Product summary
- Event
- Event 99046
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6,143 bottles
- Official record key
drug-enforcement:D-0594-2026
Official wording
Reason: Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Code information: Lot: PA00805, expires: 01/31/2029
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Unknown
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.