Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, M...
FDA Recall #D-0371-2024 — Class II — February 7, 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.
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office — Richmond, VA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
70 vials
Distribution
Product was distributed to three direct accounts in NM, AZ and UT.
Code Information
1064081
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated