FDAClass IINovember 8, 2017

ROCuronium Bromide 10 mg per mL recall: Sterility Concern

ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock…

Why was ROCuronium Bromide 10 mg per mL recalled?

Lack Of Assurance Of Sterility.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 20171004@4 BUD: 01/09/2018

Product
ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock…
Recalling firm
SCA Pharmaceuticals, LLC
Quantity
487 syringes
Distribution
Nationwide in the United States
Recall date
November 8, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls