Drug product
HYDROcodone BITARTRATE/ ACETAMINOPHEN Tablet, 7.5 mg/325 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 52544016201
D-609-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-609-2014
Official wording
Reason: Labeling: Label Mixup; HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: W003999, EXP: 7/1/2014.
Code information: HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg has the following code Pedigree: W004005, EXP: 7/1/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled