Drug product
Rocuronium Bromide 50 MG/5ML INJ., Qty: 5 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack Inc., 625 Kolter Dr., Indiana, PA 15701, NDC 61786-0222-57
D-0517-2016
Product summary
- Event
- Event 72699
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 Vials
- Official record key
drug-enforcement:D-0517-2016
Official wording
Reason: Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Code information: Lot#: B0073852-030915, Exp 04/2016
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect