Recalls / Class II
Class IID-951-2014
Product
hydrOXYzine PAMOATE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00555032402.
- Affected lot / code info
- 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.
Why it was 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
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 800 Capsules
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-20
- Posted by FDA
- 2014-01-29
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-951-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.