Recalls / Class II
Class IID-1022-2014
Product
THIAMINE HCL, Tablet, 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904054460.
- Affected lot / code info
- THIAMINE HCL, Tablet, 100 mg has the following codes: Pedigree: AD70639_1, EXP: 5/29/2014; Pedigree: AD54559_1, EXP: 5/20/2014; Pedigree: AD52993_16, EXP: 5/20/2014; Pedigree: W003408, EXP: 6/19/2014.
Why it was recalled
Labeling: Label Mixup: THIAMINE HCL, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: SIMVASTATIN, Tablet, 5 mg, NDC 00093715298, Pedigree: AD65323_13, EXP: 5/29/2014; CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units, NDC 00904323392, Pedigree: AD54576_1, EXP: 5/20/2014; BUPRENORPHINE HCL SL, Tablet, 2 mg, NDC 00054017613, Pedigree: AD54478_1, EXP: 5/20/2014; P
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 500 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-1022-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.