Recalls / Class II

Class IID-497-2014

Product

MELATONIN, Tablet, 3 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 08770140813

Affected lot / code info

MELATONIN, Tablet, 3 mg has the following codes Pedigree: AD46257_56, EXP: 5/15/2014; Pedigree: W003022, EXP: 6/12/2014; Pedigree: W003723, EXP: 6/26/2014; Pedigree: AD21846_34, EXP: 5/1/2014; Pedigree: AD30028_28, EXP: 5/7/2014; Pedigree: AD60240_39, EXP: 5/22/2014; Pedigree: AD73521_31, EXP: 5/30/2014; Pedigree: W002701, EXP: 6/5/2014; Pedigree: W003320, EXP: 6/19/2014.

Why it was recalled

Labeling: Label Mixup; MELATONIN, Tablet, 3 mg may be potentially mislabeled as VITAMIN B COMPLEX, Capsule, NDC 00536478701, Pedigree: AD32757_4, EXP: 5/13/2014; MULTIVITAMIN/ MULTIMINERAL/ LUTEIN, Capsule, NDC 24208063210, Pedigree: W003025, EXP: 6/12/2014; LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: W003721, EXP: 6/26/2014; GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

14301 Se 1st St, Vancouver, Washington 98684-3501

Distribution

Quantity

3,710 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-497-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.