FDAClass IIJanuary 29, 2014

Pregabalin recall: Labeling Error

PREGABALIN, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00071101768.

Why was Pregabalin recalled?

Labeling: Label Mixup: PREGABALIN, Capsule, 200 mg may have potentially been mislabeled as one of the following drugs: LOSARTAN POTASSIUM, Tablet, 50 mg, NDC 00781570192, Pedigree: AD21965_10, EXP: 5/1/2014; CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: AD30180_25, EXP: 5/9/2014; clonazePAM, Tablet, 0.25 mg (1/2 of 0.5 mg), NDC 00093083201, Pedigree: AD73518_1, EXP: 5/31/2014; OM

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?

Labeling: Label Mixup: PREGABALIN, Capsule, 200 mg has the following codes: Pedigree: AD21787_1, EXP: 5/1/2014; Pedigree: AD30024_1, EXP: 5/9/2014; Pedigree: AD73518_4, EXP: 5/31/2014; Pedigree W002759, EXP: 6/6/2014; Pedigree: W003397, EXP: 6/19/2014; Pedigree: W003398, EXP: 6/19/2014.

Product
PREGABALIN, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00071101768.
Recalling firm
Aidapak Services, LLC
Quantity
540 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)
Open FDA enforcement record Latest recalls