PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 20, 2024 Initiated: February 7, 2024 #D-0371-2024

Product Description

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

Reason for Recall

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

Details

Units Affected
70 vials
Distribution
Product was distributed to three direct accounts in NM, AZ and UT.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 70 vials.
Why was this product recalled?
cGMP Deviations: Products were stored outside the drug label specifications.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 20, 2024. Severity: Moderate. Recall number: D-0371-2024.