FDAClass IIDecember 21, 2016

Rocuronium Bromide 50 mg/5 mL Injection Solution recall: Sterility Concern

Rocuronium Bromide 50 mg/5 mL Injection Solution, 5 mL (10 mg/mL) Single-Dose Syringe, Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co.…

Why was Rocuronium Bromide 50 mg/5 mL Injection Solution recalled?

Lack of Assurance of Sterility - the firm is recalling select sterile drug products.

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: 8995

Product
Rocuronium Bromide 50 mg/5 mL Injection Solution, 5 mL (10 mg/mL) Single-Dose Syringe, Injection Solution For Slow IV Use, Rx Only, Cantrell Drug Co.…
Recalling firm
Cantrell Drug Company
Quantity
5067 syringes
Distribution
Nationwide
Recall date
December 21, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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