Recalls / Class II

Class IID-537-2014

Product

LACTASE ENZYME Tablet, 3000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 24385014976

Affected lot / code info

LACTASE ENZYME Tablet, 3000 units has the following codes Pedigree: AD21846_31, EXP: 5/1/2014; Pedigree: W003721, EXP: 6/26/2014; Pedigree: AD30028_25, EXP: 5/7/2014; Pedigree: AD60240_36, EXP: 5/22/2014; Pedigree: W002700, EXP: 6/5/2014; Pedigree: AD46257_53, EXP: 5/15/2014; Pedigree: W003021, EXP: 6/12/2014.

Why it was recalled

Labeling: Label Mixup; LACTASE ENZYME Tablet, 3000 units may be potentially mislabeled as BENZOCAINE/MENTHOL, LOZENGE, 15 mg/3.6 mg, NDC 63824072016, Pedigree: AD21811_4, EXP: 5/1/2014; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg, NDC 46122010478, Pedigree: W003722, EXP: 4/30/2014; guaiFENesin ER, Tablet, 600 mg, NDC 45802049878, Pedigree: AD30140_37, EXP: 5/7/2014; CALCIUM

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

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

Distribution

Quantity

2,872 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-537-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.