FDAClass IIJanuary 29, 2014

Loxapine recall: Labeling Error

LOXAPINE, Capsule, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591036901.

Why was Loxapine recalled?

Labeling: Label Mixup: LOXAPINE, Capsule, 5 mg may have potentially been mislabeled as the following drug: SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: AD46426_1, EXP: 5/15/2014.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

LOXAPINE, Capsule, 5 mg has the following codes: Pedigree: AD46426_7, EXP: 5/15/2014.

Product
LOXAPINE, Capsule, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591036901.
Recalling firm
Aidapak Services, LLC
Quantity
100 Capsules
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 29, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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