Drug product
guanFACINE HC, Tablet, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378116001.
D-895-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 Tablets
- Official record key
drug-enforcement:D-895-2014
Official wording
Reason: Labeling: Label Mixup: guanFACINE HC, Tablet, 1 mg may have potentially been mislabeled as one of the following drugs: glyBURIDE, Tablet, 2.5 mg, NDC 00093834301, Pedigree: AD46265_22, EXP: 5/15/2014; FOSINOPRIL SODIUM, Tablet, 10 mg, NDC 60505251002, Pedigree: AD46414_19, EXP: 5/16/2014; chlorproMAZINE HCl, Tablet, 100 mg, NDC 00832030300, Pedigree: AD70629_4, EXP: 5/29/2014; guanFACINE HCl,
Code information: guanFACINE HC, Tablet, 1 mg has the following codes: Pedigree: AD46265_25, EXP: 5/15/2014; Pedigree: AD46414_22, EXP: 5/16/2014; Pedigree: AD70629_7, EXP: 5/29/2014; Pedigree: W003007, EXP: 6/12/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled