Recalls / Class II
Class IID-876-2014
Product
SENNOSIDES, Tablet, 8.6 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00182109301.
- Affected lot / code info
- SENNOSIDES, Tablet, 8.6 mg has the following codes: Pedigree: AD62992_14, EXP: 5/23/2014; Pedigree: W002979, EXP: 6/11/2014; Pedigree: W003256, EXP: 6/17/2014.
Why it was recalled
Labeling: Label Mixup: SENNOSIDES, Tablet, 8.6 mg may have potentially been mislabeled as one of the following drugs: FEXOFENADINE HCL, Tablet, 180 mg, NDC 41167412003, Pedigree: AD62834_1, EXP: 5/23/2014; TRIMETHOBENZAMIDE HCL, Capsule, 300 mg, NDC 53489037601, Pedigree: W002976, EXP: 6/11/2014; LORATADINE, Tablet, 10 mg, NDC 45802065078, Pedigree: W003253, EXP: 6/17/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 1400 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-876-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.