Drug product
HYDROCORTISONE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603389919.
D-984-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 250 Tablets
- Official record key
drug-enforcement:D-984-2014
Official wording
Reason: Labeling: Label Mixup: HYDROCORTISONE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: carBAMazepine ER, Tablet, 200 mg, NDC 51672412401, Pedigree: AD60272_7, EXP: 5/22/2014; guanFACINE HCl, Tablet, 1 mg, NDC 00591044401, Pedigree: W002728, EXP: 4/30/2014; glyBURIDE, Tablet, 1.25 mg, NDC 00093834201, Pedigree: AD21790_10, EXP: 2/28/2014; ACARBOSE, Tablet, 25 mg
Code information: HYDROCORTISONE, Tablet, 5 mg has the following codes: Pedigree: AD60272_13, EXP: 5/22/2014; Pedigree: W002729, EXP: 6/6/2014; Pedigree: AD21790_16, EXP: 5/1/2014; Pedigree: W003060, EXP: 6/12/2014; Pedigree: W003325, EXP: 6/18/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled