RemedyRepack Inc. recalls Rocuronium Bromide 50 MG/5ML INJ., Qty: 5 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: Reme…

Recall date

November 11, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0517-2016

FDA classification

Class II

Brand / firm

RemedyRepack Inc.

Sold / distributed

Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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