FDAClass IIMarch 20, 2024

Rocuronium Bromide Injection recall: CGMP Deviations

Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10

Why was Rocuronium Bromide Injection recalled?

cGMP Deviations: Products were stored outside the drug label specifications.

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?

1064081

Product
Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10
Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Quantity
70 vials
Distribution
Product was distributed to three direct accounts in NM, AZ and UT.
Recall date
March 20, 2024
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls