Aidapak Recalls Loxapine Capsules Due to Potential Sertraline Labeling Error
Aidapak Services, LLC is recalling Loxapine 5 mg capsules that may have been mislabeled as Sertraline HCL 50 mg tablets. The repacked drugs were distributed in four western states.
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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as taking the wrong medication) are assigned a severity score of 4 (Severe).
Plain-English summary
Aidapak Services, LLC is recalling Loxapine, Capsule, 5 mg, NDC 00591036901, due to a labeling error. The source text indicates that the Loxapine capsules may have been mislabeled as Sertraline HCL, Tablet, 50 mg, NDC 16714061204. Both products share the same pedigree code (AD46426) and expiration date (5/15/2014), though the pedigree suffixes differ slightly in the provided data.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should check their inventory for Loxapine 5 mg capsules with the specified NDC and expiration date. 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 taken the medication and experience any adverse effects.
The recalled product
- Product
- LOXAPINE, Capsule, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591036901.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- 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)
- LOXAPINE
- Capsule
- 5 mg has the following codes: Pedigree: AD46426_7
- EXP: 5/15/2014.
Distribution
Part of a larger recall action
This product is one of 265 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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