Recalls / Class II
Class IID-0517-2016
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
- Affected lot / code info
- Lot#: B0073852-030915, Exp 04/2016
Why it was recalled
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, N/A, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 4 Vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-11-11
- FDA classified
- 2015-12-04
- Posted by FDA
- 2015-12-16
- Terminated
- 2016-11-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0517-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.