Aripiprazole Tablets Recalled for Potential Labeling Mixup
Aidapak Services is recalling Aripiprazole 2 mg tablets because they may be mislabeled as other prescription drugs.
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: The recall involves a labeling mixup where a medication may be mislabeled as a different drug, which poses a risk of harm if the wrong medication is administered, but no injuries or illnesses have been reported.
Plain-English summary
Aidapak Services, LLC is recalling Aripiprazole Tablet, 2 mg (NDC 5914800013) due to a labeling mixup. The recalled tablets may be potentially mislabeled as other prescription medications, including tizanidine HCl, atomoxetine HCl, olanzapine, or repaglinide.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall involves specific pedigree codes and expiration dates ranging from May 2014 to June 2014.
Consumers and healthcare providers should check their inventory for the affected NDC and pedigree codes. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions about their medication.
The recalled product
- Product
- ARIPiprazole Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59148000613
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 180
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 (12)
- ARIPiprazole
- Tablet
- 2 mg has the following codes Pedigree: AD21790_43
- EXP: 5/1/2014
- Pedigree: AD30140_25
- EXP: 5/7/2014
- Pedigree: AD46265_19
- EXP: 5/15/2014
- Pedigree: AD46414_1
- EXP: 5/16/2014
- Pedigree: W003004
- EXP: 6/11/2014.
Distribution
Part of a larger recall action
This product is one of 273 recalled by Aidapak Services, LLC 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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