Drug product
MISOPROSTOL, Tablet, 200 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762500801
D-649-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 120 Tablets
- Official record key
drug-enforcement:D-649-2014
Official wording
Reason: Labeling:Label Mixup; MISOPROSTOL Tablet, 200 mcg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: AD21790_34, EXP: 5/1/2014; SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: W003115, EXP: 6/13/2014.
Code information: MISOPROSTOL, Tablet, 200 mcg has the following codes Pedigree: AD21965_13, EXP: 5/1/2014; Pedigree: W003117, EXP: 6/13/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled