FDA recall D-0371-2024

Mckesson Medical-Surgical Inc. Corporate Office · Class II · drug

Product

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.

Distribution

Product was distributed to three direct accounts in NM, AZ and UT.

Key facts

Status
Terminated
Initiation date
2024-02-07
Report date
2024-03-20
Termination date
2024-08-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Richmond, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0371-2024