Oxybutynin Chloride recall: Labeling Error
OXYBUTYNIN CHLORIDE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603497521.
Why was Oxybutynin Chloride recalled?
Labeling: Label Mixup: OXYBUTYNIN CHLORIDE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: FLECAINIDE ACETATE, Tablet, 100 mg, NDC 00054001125, Pedigree: AD56847_4, EXP: 5/21/2014; SODIUM CHLORIDE, Tablet, 1 gm, NDC 00223176001, Pedigree: W003792, EXP: 6/27/2014; VARENICLINE, Tablet, 0.5 mg, NDC 00069046856, Pedigree: AD22616_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?
OXYBUTYNIN CHLORIDE, Tablet, 5 mg has the following codes: Pedigree: AD52778_61, EXP: 5/20/2014; Pedigree: W003898, EXP: 6/27/2014; Pedigree: AD22616_4, EXP: 5/2/2014.
- Product
- OXYBUTYNIN CHLORIDE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603497521.
- Recalling firm
- Aidapak Services, LLC
- Quantity
- 299 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)