Recalls / Class II
Class IID-487-2014
Product
CHOLECALCIFEROL, Capsule, 5000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 0904598660
- Affected lot / code info
- CHOLECALCIFEROL, Capsule, 5000 units has the following codes Pedigree: AD70629_19, EXP: 5/29/2014; Pedigree: W003541, EXP: 6/21/2014; Pedigree: AD52993_22, EXP: 5/20/2014.
Why it was recalled
Labeling: Label Mixup; CHOLECALCIFEROL, Capsule, 5000 units may be potentially mislabeled as SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD70629_16, EXP: 5/29/2014; CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W003540, EXP: 6/21/2014; THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedigree: AD52993_16, EXP: 5/20/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 300 Capsules
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-16
- Posted by FDA
- 2014-01-22
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-487-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.