FDA recall record

Aidapak Services REPAGLINIDE, Tablet, 2 mg recall — FDA D-869-2014

Labeling: Label Mixup: REPAGLINIDE, Tablet, 2 mg may have potentially been mislabeled as one of the following drugs: COLCHICINE, Tablet, 0.6 mg, NDC…

Class IIclassification
D-869-2014official record ID
Jan 29, 2014report date

Recall record at a glance

Official recordD-869-2014
CategoryDrug Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmAidapak Services, LLC
Report dateJan 29, 2014
Recall initiation dateJul 2, 2013
Quantity500 Tablets
LocationVancouver, WA, United States

Official product description

REPAGLINIDE, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00169008481.

Why the product was recalled

Labeling: Label Mixup: REPAGLINIDE, Tablet, 2 mg may have potentially been mislabeled as one of the following drugs: COLCHICINE, Tablet, 0.6 mg, NDC 64764011907, Pedigree: AD46419_1, EXP: 5/16/2014; PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, NDC 00032121207, Pedigree: AD70639_7, EXP: 5/29/2014; DARUNAVIR, Tablet, 800 mg, NDC 59676056630, Pedigree: W003929, EXP: 7/1/2014.

Distribution information

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Telephone.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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