Drug product
FAMCICLOVIR, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093811956.
D-851-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 Tablets
- Official record key
drug-enforcement:D-851-2014
Official wording
Reason: 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.
Code information: FAMCICLOVIR, Tablet, 500 mg has the following codes: Pedigree: AD49448_4, EXP 5/17/2014; Pedigree: AD54549_4, EXP: 5/20/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled