FDA Drug Recalls

Recalls / Class II

Class IID-941-2014

Product

PYRIDOXINE HCL, Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536440801.

Affected lot / code info
PYRIDOXINE HCL, Tablet, 50 mg has the following codes: Pedigree: W003824, EXP: 6/27/2014; Pedigree: AD30197_22, EXP: 5/9/2014; Pedigree: AD60428_10, EXP: 5/22/2014.

Why it was recalled

Labeling: Label Mixup: PYRIDOXINE HCL, Tablet, 50 mg may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS GG, Capsule, 15 Billion Cells, NDC 49100036374, Pedigree: W003787, EXP: 6/27/2014; LEVOTHYROXINE/ LIOTHYRONINE, Tablet, 19 mcg/4.5 mcg, NDC 42192032901, Pedigree: AD30197_19, EXP: 3/31/2014; CALCIUM/ CHOLECALCIFEROL/ SODIUM, Tablet, 600 mg/400 units/5 mg, NDC 00

Recalling firm

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

Distribution

Quantity
695 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-941-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.