Rocuronium Bromide 50 MG/5ML INJ., Qty: 5 mL Vial, MFG by: Mylan Institutional, Rockford, IL 6110...
FDA Recall #D-0517-2016 — Class II — November 11, 2015
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.
Recalling Firm
RemedyRepack Inc. — Indiana, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4 Vials
Distribution
Nationwide
Code Information
Lot#: B0073852-030915, Exp 04/2016
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated