The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0517-2016·Announced 2015-12-16

RemedyRepack Recalls Rocuronium Bromide Vials Due to Incorrect Storage Instructions

RemedyRepack Inc. is recalling Rocuronium Bromide 50 mg/5 mL vials because the product labels contain incorrect storage instructions.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to a labeling error (incorrect storage instructions). Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses fall under the Moderate severity level.

Plain-English summary

RemedyRepack Inc. is recalling Rocuronium Bromide 50 MG/5ML INJ. vials (NDC 61786-0222-57) due to incorrect storage instructions on the product labels. The product was manufactured by Mylan Institutional and repackaged by RemedyRepack Inc. The recall involves 4 vials per unit, with a lot number of B0073852-030915 and an expiration date of 04/2016.

The recall was initiated because the labeling provided incorrect instructions for storing the medication. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and patients who have this specific lot of Rocuronium Bromide should stop using the product and contact their healthcare provider or the recalling firm for further instructions. The product was distributed nationwide.

The recalled product

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
Manufacturer
RemedyRepack Inc.
Category
Drug — Injectable Medication
Hazard
Affected units
4

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot#: B0073852-030915
  • Exp 04/2016

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by RemedyRepack Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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