The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0490-2023·Announced 2023-04-12

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.

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 2/5 (Moderate).

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
Affected units
3

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.

Part of a larger recall action

This product is one of 14 recalled by RemedyRepack 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.

See all 14 products in this recall →

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