FDA Drug Recalls

Recalls / Class II

Class IID-883-2014

Product

SODIUM CHLORIDE, Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00223176001.

Affected lot / code info
SODIUM CHLORIDE, Tablet, 1 mg has the following codes: Pedigree: AD39560_1, EXP: 5/13/2014; Pedigree: AD70636_1, EXP: 5/29/2014; Pedigree: AD73662_1, EXP: 6/3/2014; Pedigree: W002611, EXP: 6/4/2014; Pedigree: W003792, EXP: 6/27/2014; Pedigree: AD22845_10, EXP: 5/2/2014; Pedigree: W003115, EXP: 6/13/2014; Pedigree: W003707, EXP: 6/25/2014.

Why it was recalled

Labeling: Label Mixup: SODIUM CHLORIDE, Tablet, 1 mg may have potentially been mislabeled as one of the following drugs: BISACODYL EC, Tablet, 5 mg, NDC 00904792760, Pedigree: AD34931_1, EXP: 5/9/2014; DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071215, Pedigree: AD70633_1, EXP: 5/29/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W002509, EXP: 6/3/2014; SODIUM CHLORIDE, Tabl

Recalling firm

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

Distribution

Quantity
7891 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-883-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls