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Recall Observatory FDA recall evidence

Drug product

LITHIUM CARBONATE ER, Tablet, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054002125.

D-791-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
2400 Tablets
Official record key
drug-enforcement:D-791-2014

Official wording

Reason: Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 300 mg may be potentially mislabled as the following drug: VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50 mg, NDC 40985022251, Pedigree: AD39588_10, EXP: 5/13/2014.

Code information: LITHIUM CARBONATE ER, Tablet, 300 mg has the following codes: Pedigree: AD39564_1, EXP: 5/13/2014.

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mixup