FDAClass IIJanuary 29, 2014

Mesalamine DR recall: Labeling Error

MESALAMINE DR, Capsule, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00430075327.

Why was Mesalamine DR recalled?

Labeling: Label Mixup: MESALAMINE DR, Capsule, 400 mg may have potentially been mislabeled as the following drug: CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg, NDC 11868000901, Pedigree: AD34928_1, EXP: 5/9/2014.

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?

MESALAMINE DR, Capsule, 400 mg has the following codes: Pedigree: AD34934_1, EXP: 1/31/2014.

Product
MESALAMINE DR, Capsule, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00430075327.
Recalling firm
Aidapak Services, LLC
Quantity
180 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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