Skip to content
Recall Observatory FDA recall evidence

Drug product

LITHIUM CARBONATE ER, Tablet, 450 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054002025.

D-790-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
1899 Tablets
Official record key
drug-enforcement:D-790-2014

Official wording

Reason: Labeling: Label Mixup: LITHIUM CARBONATE ER, Tablet, 450 mg may be potentially mislabled as one of the following drugs: HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD21790_19, EXP: 5/1/2014; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 MILLION CFU, NDC 43292050022, Pedigree: AD46257_28, EXP: 5/15/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W002729, EXP: 6

Code information: LITHIUM CARBONATE ER, Tablet, 450 mg has the following codes: Pedigree: AD21790_28, EXP: 5/1/2014 Pedigree: AD46265_10, EXP: 5/15/2014 Pedigree: W002730, EXP: 6/6/2014 Pedigree: W003681, EXP: 6/25/2014 Pedigree: AD60272_25, EXP: 5/22/2014 Pedigree: AD62796_1, EXP: 5/22/2014 Pedigree: W003327, EXP: 6/19/2014.

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