Aripiprazole 30mg bottle contained voriconazole 50mg tablets instead
Aripiprazole Tablets USP 30 mg from Ajanta Pharma are being recalled after a bottle containing Voriconazole Tablets 50 mg was labelled and distributed as aripiprazole. 6,143 bottles affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm defect where a patient could receive an entirely different medicine than the one prescribed, with no injuries reported in the source.
Plain-English summary
Aripiprazole Tablets USP, 30 mg, 30 tablets per bottle, prescription only, marketed by Ajanta Pharma USA Inc. of Bridgewater, New Jersey and made in India, NDC 27241-056-03, is being recalled. The action covers 6,143 bottles.
The stated reason is a product mix-up: a bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg. The FDA classified the action as Class II.
The affected lot is PA00805, expiring 01/31/2029. Distribution was USA nationwide.
Patients should not stop taking a prescribed medicine without advice. Anyone holding the affected lot should check the tablets against what was prescribed, speak to their pharmacist or prescriber, and follow the instructions issued by the firm.
The recalled product
- Product
- ARIPIPRAZOLE (ARIPIPRAZOLE)
- Brand
- ARIPIPRAZOLE
- Manufacturer
- Ajanta Pharma USA Inc
- Category
- Drug — Antipsychotic tablet
- Affected units
- 6,143
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: PA00805
- expires: 01/31/2029
UPCs (6)
- 0327241051036
- 0327241055034
- 0327241053030
- 0327241056031
- 0327241054037
- 0327241052033
Distribution
Distributed nationwide across the United States.
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