FDA recall D-790-2014

Aidapak Services, LLC · Class II · drug

Product

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

Reason for recall

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

Distribution

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

Key facts

Status: Terminated
Initiation date: 2013-07-02
Report date: 2014-01-29
Termination date: 2014-02-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Vancouver, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-790-2014