Recalls / Class II
Class IID-790-2014
Product
LITHIUM CARBONATE ER, Tablet, 450 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054002025.
- Affected lot / code info
- 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.
Why it was recalled
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
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 1899 Tablets
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-20
- Posted by FDA
- 2014-01-29
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-790-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.