Recalls / Class II
Class IID-568-2014
Product
FEXOFENADINE HCl Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45802042578
- Affected lot / code info
- FEXOFENADINE HCL Tablet, 60 mg has the following codes Pedigree: W003020, EXP: 6/12/2014; Pedigree: AD60240_30, EXP: 5/22/2014; Pedigree: AD46257_50, EXP: 5/15/2014.
Why it was recalled
Labeling: Label Mixup; FEXOFENADINE HCL Tablet, 60 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree: W003019, EXP: 6/12/2014; NIACIN TR, Capsule, 500 mg, NDC 00904063160, Pedigree: AD60240_17, EXP: 5/22/2014; CRANBERRY EXTRACT/VITAMIN C, Capsule, 450 mg/125 mg, NDC 31604014271, Pedigree: AD46257_13, EXP: 5/15/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 300 Tablets
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-16
- Posted by FDA
- 2014-01-22
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-568-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.