Pimozide Tablets Recalled for Potential Labeling Mixup
Aidapak Services is recalling Pimozide 2 mg tablets because they may be mislabeled as Duloxetine HCl 20 mg capsules.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of administering the wrong medication.
Plain-English summary
Aidapak Services, LLC is recalling Pimozide Tablet, 2 mg, NDC 57844018701. The recall is due to a labeling mixup where the Pimozide tablets may be potentially mislabeled as Duloxetine HCl DR, Capsule, 20 mg, NDC 00002323560.
The affected Pimozide tablets have the pedigree AD30140_43 and an expiration date of 5/7/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Healthcare providers and patients should check their inventory for the specific NDC and pedigree listed above. If the product is found, it should be quarantined and returned to the distributor or manufacturer for further instructions.
The recalled product
- Product
- PIMOZIDE Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57844018701
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Tablets
- Hazard
- Affected units
- 100
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 (4)
- PIMOZIDE
- Tablet
- 2 mg has the following code Pedigree: AD30140_43
- EXP: 5/7/2014.
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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