FDA Drug Recalls

Recalls / Class II

Class IID-1017-2014

Product

PYRIDOXINE HCL, Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904052060.

Affected lot / code info
PYRIDOXINE HCL, Tablet, 50 mg has the following codes: Pedigree: AD22865_19, EXP: 5/2/2014; Pedigree: AD46312_34, EXP: 5/16/2014; Pedigree: AD22865_22, EXP: 5/2/2014; Pedigree: W003257, EXP: 6/17/2014.

Why it was recalled

Labeling: Label Mixup: PYRIDOXINE HCL, Tablet, 50 mg may have potentially been mislabeled as one of the following drugs: MELATONIN, Tablet, 1 mg, NDC 04746900466, Pedigree: AD21846_17, EXP: 5/1/2014; METHOCARBAMOL, Tablet, 500 mg, NDC 00143129001, Pedigree: AD46312_28, EXP: 5/16/2014; LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00074929690, Pedigree: AD22865_16, EXP: 5/2/2014; RILUZOLE, Tablet,

Recalling firm

Firm
Aidapak Services, LLC
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
14301 Se 1st St, Vancouver, Washington 98684-3501

Distribution

Quantity
403 Tablets
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-1017-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.