← FDA ENFORCEMENT
D-0371-2024Class II

Mckesson Medical-Surgical Inc. Corporate Office

Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Product type
Drug
Status
Terminated
Report date
2024-03-20
Distribution
Product was distributed to three direct accounts in NM, AZ and UT.
Firm state
VA
Product quantity
70 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

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

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

Code / lot info

1064081

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.