FDA recall D-537-2014

Aidapak Services, LLC · Class II · drug

Product

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

Reason for recall

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

Distribution

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Key facts

Status: Terminated
Initiation date: 2013-07-02
Report date: 2014-01-22
Termination date: 2014-02-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Vancouver, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-537-2014