PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: December 16, 2015 Initiated: November 11, 2015 #D-0517-2016

Product Description

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

Reason for Recall

Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.

Details

Recalling Firm
RemedyRepack Inc.
Units Affected
4 Vials
Distribution
Nationwide
Location
Indiana, PA

Frequently Asked Questions

What product was recalled?
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. Recalled by RemedyRepack Inc.. Units affected: 4 Vials.
Why was this product recalled?
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 16, 2015. Severity: Moderate. Recall number: D-0517-2016.