hydrOXYzine PAMOATE recall: Labeling Error
hydrOXYzine PAMOATE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00555032402.
Why was hydrOXYzine PAMOATE recalled?
Labeling: Label Mixup: hydrOXYzine PAMOATE, Capsule, 100 mg may have potentially been mislabeled as one of the following drugs: CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium), NDC 00904506260, AD46257_43, EXP: 5/15/2014; guaiFENesin ER, Tablet, 600 mg, NDC 45802049878, Pedigree: W002734, EXP: 6/6/2014; guaiFENesin ER, Tablet, 600 mg, NDC 45802049878, Pedigree: W003689, EXP: 6/26/20
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?
hydrOXYzine PAMOATE, Capsule, 100 mg has the following codes: Pedigree: AD46265_28, EXP: 5/15/2014; Pedigree: W002735, EXP: 6/6/2014; Pedigree: W003690, EXP: 6/26/2014; Pedigree: AD21790_61, EXP: 5/1/2014; Pedigree: AD60272_67, EXP: 5/22/2014; Pedigree: W003008, EXP: 6/11/2014; Pedigree: W003332, EXP: 6/18/2014.
- Product
- hydrOXYzine PAMOATE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00555032402.
- Recalling firm
- Aidapak Services, LLC
- Quantity
- 800 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)