Drug Recall: Aripiprazole 5mg Tablets Due to Manufacturing Practice Deviations
RemedyRepack Inc. is recalling Aripiprazole 5mg tablets (lot J0620431-052322) due to cGMP deviations affecting manufacturing practices. The voluntary recall includes 3 bottles distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a FDA Class II voluntary recall with no reported illnesses or injuries. The hazard is cGMP deviations in manufacturing practices rather than a specific identified contaminant or defect. Such precautionary recalls due to manufacturing process issues are classified as Moderate (2) severity.
Plain-English summary
RemedyRepack Inc. is recalling Aripiprazole 5mg tablets in 30-count bottles due to manufacturing practice deviations. The affected product is lot J0620431-052322, which expired May 31, 2023. RemedyRepack distributed a total of 3 bottles of the recalled product to consignees nationwide within the United States.
The recall was initiated because the product did not meet current Good Manufacturing Practice (cGMP) standards. cGMP deviations indicate that the manufacturing or repackaging process did not comply with FDA requirements for pharmaceutical production.
Patients who have bottles of Aripiprazole 5mg tablets with lot number J0620431-052322 should not use the product and should contact their healthcare provider or pharmacist. Those with this lot number should return the product to their pharmacy or dispose of it according to local regulations.
The recalled product
- Product
- Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921-03
- Manufacturer
- RemedyRepack Inc.
- Category
- Drug
- Hazard
- gmp-deviation
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 #: J0620431-052322
- Exp. Date 05/31/23
Distribution
Distributed nationwide across the United States.
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