FDAClass IIApril 15, 2020

rocuronium Bromide 10 mg per mL 50 mg per recall: Sterility Concern

rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Free, NDC…

Why was rocuronium Bromide 10 mg per mL 50 mg per recalled?

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

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?

193510017D 3/17/2020 193530001D 3/19/2020 193540002D 3/22/2020

Product
rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave. Cleveland, MS. Preservative Free, NDC…
Recalling firm
PharMEDium Services, LLC
Quantity
4625 units
Distribution
Distributed Nationwide in the US
Recall date
April 15, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls