Drug product
MISOPROSTOL Tablet, 100 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386016012
D-564-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 120 Tablets
- Official record key
drug-enforcement:D-564-2014
Official wording
Reason: Labeling: Label Mixup; MISOPROSTOL Tablet, 100 mcg may be potentially mislabeled as QUINAPRIL HCL, Tablet, 10 mg, NDC 59762502001, Pedigree: AD42611_4, EXP: 5/14/2014.
Code information: MISOPROSTOL, Tablet, 100 mcg has the following code Pedigree: AD42611_7, EXP: 5/14/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled