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Recall Observatory FDA recall evidence

Drug product

THYROID, Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00456045801.

D-913-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
300 Tablets
Official record key
drug-enforcement:D-913-2014

Official wording

Reason: Labeling: Label Mixup: THYROID, Tablet, 30 mg may have potentially been mislabeled as one of the following drugs: OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg, NDC 11523726503, Pedigree: AD70655_20, EXP: 5/29/2014; NICOTINE POLACRILEX, LOZENGE, 2 mg, NDC 37205098769, Pedigree: AD73623_7, EXP: 5/30/2014; PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree: W002697, EXP: 6/5/2014.

Code information: THYROID, Tablet, 30 mg has the following codes: Pedigree: AD65323_1, EXP: 5/29/2014; Pedigree: AD73611_1, EXP: 5/30/2014; Pedigree: W002847, EXP: 6/7/2014.

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