← FDA ENFORCEMENT
D-0371-2024Class II
Mckesson Medical-Surgical Inc. Corporate Office
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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 ControlReason 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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See all Documentation & Change Control recalls →Data: U.S. FDA. 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. Open the enforcement explorer →