Drug product
HYDROCHLOROTHIAZIDE, Tablet, 12.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00228282011.
D-886-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 Tablets
- Official record key
drug-enforcement:D-886-2014
Official wording
Reason: Labeling: Label Mixup: HYDROCHLOROTHIAZIDE, Tablet, 12.5 mg may have potentially been mislabeled as one of the following drugs: hydrALAZINE HCl, Tablet, 100 mg, NDC 23155000401, Pedigree: AD73652_4, EXP: 5/29/2014; CLINDAMYCIN HCL, Capsule, 300 mg, NDC 00591312001, Pedigree: AD67989_1, EXP: 5/28/2014.
Code information: HYDROCHLOROTHIAZIDE, Tablet, 12.5 mg has the following codes: Pedigree: AD73652_7, EXP: 5/29/2014 Pedigree: AD67989_13, EXP: 5/28/2014
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled