Recalls / Class II
Class IID-851-2014
Product
FAMCICLOVIR, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093811956.
- Affected lot / code info
- FAMCICLOVIR, Tablet, 500 mg has the following codes: Pedigree: AD49448_4, EXP 5/17/2014; Pedigree: AD54549_4, EXP: 5/20/2014.
Why it was recalled
Labeling: Label Mixup: FAMCICLOVIR, Tablet, 500 mg may have potentially been mislabeled as one of the following drugs: TOLTERODINE TARTRATE ER, Capsule, 4 mg, NDC 00009519101, Pedigree: AD49448_1, EXP: 5/17/2014; THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedigree: AD54559_1, 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
- 60 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-851-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.