Drug product
LITHIUM CARBONATE ER, Tablet, 450 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054002025.
D-790-2014
Product summary
- 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
Labeling: Label Mixup