FDAClass IIJanuary 29, 2014

Buprenorphine HCL SL recall: Labeling Error

BUPRENORPHINE HCL SL, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054017613.

Why was Buprenorphine HCL SL recalled?

Labeling: Label Mixup: BUPRENORPHINE HCL SL, Tablet, 2 mg may be potentially mislabeled as one of the following drugs: DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD37072_4, EXP: 5/13/2014; MAGNESIUM CHLORIDE DR, Tablet, 64 mg, NDC 00904791152, Pedigree: AD54510_1, EXP: 2/28/2014.

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?

BUPRENORPHINE HCL SL, Tablet, 2 mg has the following codes: Pedigree: AD39573_1, EXP: 5/13/2014; Pedigree: AD54478_1, EXP: 5/20/2014.

Product
BUPRENORPHINE HCL SL, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054017613.
Recalling firm
Aidapak Services, LLC
Quantity
60 Tablets
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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