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Class II: temporary or reversible health riskTerminated

RemedyRepack Rocuronium Bromide 50 MG/5ML INJ Recall

Rocuronium Bromide 50 MG/5ML INJ

RemedyRepack Inc. · Indiana, PA

Risk level
Class II
Reported by FDA
Dec 16, 2015
Recall ID
D-0517-2016
Check your lot numberHow we source this data

Summary

RemedyRepack recalled Rocuronium Bromide 50 MG/5ML INJ starting Nov 11, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0517-2016 on Dec 16, 2015. Reason: Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions. Status: Terminated.

Why it was recalled

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

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

Lot numbers, UPCs & expiration codes

Lot#: B0073852-030915, Exp 04/2016

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0517-2016
Classification
Class II
Status
Terminated
Recall initiated
Nov 11, 2015
FDA report date
Dec 16, 2015
Quantity
4 Vials
Recall type
Voluntary: Firm initiated
Recalling firm
RemedyRepack Inc.

Original FDA data

Every field from FDA enforcement report D-0517-2016, exactly as published.

Show all FDA fields
City
Indiana
State
PA
Status
Terminated
Country
United States
Event ID
72699
Address
625 Kolter Dr Ste 4
Code information
Lot#: B0073852-030915, Exp 04/2016
Postal code
15701-3571
Report date
Dec 16, 2015
Product type
Drugs
Recall number
D-0517-2016
Classification
Class II
Recalling firm
RemedyRepack Inc.
Product quantity
4 Vials
Termination date
Nov 1, 2016
Reason for recall
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide
Recall initiation date
Nov 11, 2015
Initial firm notification
Letter
Center classification date
Dec 4, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0517-2016, published Dec 16, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

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