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Recall Observatory FDA recall evidence

Drug product

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

D-537-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
2,872 Tablets
Official record key
drug-enforcement:D-537-2014

Official wording

Reason: 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

Code information: 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.

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled