Aripiprazole tablets recalled due to manufacturing process deviations
Accord Healthcare is recalling 747,464 bottles of Aripiprazole 2mg tablets due to manufacturing process deviations discovered during an FDA inspection. The affected medication was distributed in the United States, Puerto Rico, and Canada.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall due to manufacturing process deviations, which by definition indicates potential for adverse health consequences. No illnesses, injuries, or deaths have been reported in the source text, placing this in the risk-of-harm category without documented adverse consequences.
Plain-English summary
Accord Healthcare, Inc. is recalling Aripiprazole 2mg tablets distributed in the United States, Puerto Rico, and Canada. A total of 747,464 bottles are affected.
The recall was initiated following the identification of Current Good Manufacturing Practice (CGMP) deviations during an FDA inspection. These deviations indicate that the manufacturing facility did not meet the required pharmaceutical quality standards and manufacturing control procedures established by the FDA.
Affected products include tablets packaged in 30-count bottles (NDC 16729-278-10) and 100-count bottles (NDC 16729-278-01), manufactured by Intas Pharmaceuticals Limited in Ahmedabad, India for Accord Healthcare, Inc. Multiple batches with expiration dates ranging from September 2023 through May 2025 are included in this recall, with batch numbers including P2005474, P2100001, P2100789, P2100790, P2101319, P2102147, P2102148, P2104084, P2105410, P2107233, P2105411, P2106671, P2106673, P2106675, P2200428, P2200429, P2200430, P2203333, P2203334, P2102940, and P2105793.
Patients taking this medication should contact their healthcare provider or pharmacist to determine if their prescription may be affected and what actions to take. Do not discontinue use of this medication abruptly without medical guidance, as sudden stopping could lead to serious adverse effects. Return affected medication to a pharmacy for proper disposal.
The recalled product
- Product
- ARIPIPRAZOLE (ARIPIPRAZOLE)
- Brand
- ARIPIPRAZOLE
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug
- Hazard
- Affected units
- 747,464
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 (20)
- Batches: a) P2005474
- Exp 9/30/2023
- P2100001
- Exp 12/31/2023
- P2100789
- P2100790
- Exp 1/31/2024
- P2101319
- Exp 2/28/2024
- P2102147
- P2102148
- Exp 3/31/2024
- P2104084
- Exp 6/30/2024
- P2105410
- P2107233
- P2105411
- Exp 7/31/2024
- P2106671
- P2106673
UPCs (1)
- 316729278102
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 67 recalled by Accord Healthcare, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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