FDAClass IIJanuary 29, 2014

Glycopyrrolate recall: Labeling Error

GLYCOPYRROLATE, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603318121.

Why was Glycopyrrolate recalled?

Labeling: Label Mixup: GLYCOPYRROLATE, Tablet, 2 mg may have potentially been mislabeled as one of the following drugs: PARICALCITOL, Capsule, 1 mcg, NDC 00074431730, Pedigree: W002667, EXP: 6/5/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000850, Pedigree: W003244, EXP: 6/17/2014; LACTOBACILLUS, Tablet, 0, NDC 64980012950, Pedigree: AD22865_1, EXP: 5/2/2014.

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?

GLYCOPYRROLATE, Tablet, 2 mg has the following codes: Pedigree: W002650, 6/5/2014; Pedigree: W003252, 6/17/2014; Pedigree: AD22865_4, 5/2/2014.

Product
GLYCOPYRROLATE, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603318121.
Recalling firm
Aidapak Services, LLC
Quantity
1300 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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