Drug product
ORPHENADRINE CITRATE ER Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386048024
D-566-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-566-2014
Official wording
Reason: Labeling: Label Mixup; ORPHENADRINE CITRATE ER Tablet, 100 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W002965, EXP: 6/10/2014.
Code information: ORPHENADRINE CITRATE ER, Tablet, 100 mg has the folowing code Pedigree: W002962, EXP: 6/11/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled