Drug product
ALBUTEROL SULFATE ER, Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378412201.
D-907-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-907-2014
Official wording
Reason: Labeling: Label Mixup: ALBUTEROL SULFATE ER, Tablet, 4 mg may have potentially been mislabeled as one of the following drugs: SIMVASTATIN, Tablet, 20 mg, NDC 16714068303, Pedigree: W003580, EXP: 6/24/2014.
Code information: ALBUTEROL SULFATE ER, Tablet, 4 mg has the following codes: Pedigree: W003578, EXP: 6/24/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled