FDAClass IIJanuary 22, 2014

Misoprostol recall: Labeling Error

MISOPROSTOL, Tablet, 200 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762500801

Why was Misoprostol recalled?

Labeling:Label Mixup; MISOPROSTOL Tablet, 200 mcg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: AD21790_34, EXP: 5/1/2014; SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: W003115, EXP: 6/13/2014.

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?

MISOPROSTOL, Tablet, 200 mcg has the following codes Pedigree: AD21965_13, EXP: 5/1/2014; Pedigree: W003117, EXP: 6/13/2014.

Product
MISOPROSTOL, Tablet, 200 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762500801
Recalling firm
Aidapak Services, LLC
Quantity
120 Tablets
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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