D-0371-2024 Class II Terminated
FDA drug recall D-0371-2024 was initiated by Mckesson Medical-Surgical Inc. Corporate Office on Feb 7, 2024 and is designated Class II. Reason for recall: cGMP Deviations: Products were stored outside the drug label specifications. The recall status is terminated (terminated Aug 14, 2024). Affected quantity: 70 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 20, 2024
- Initiation Date
- Feb 7, 2024
- Termination Date
- Aug 14, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70 vials
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.
Distribution Pattern
Product was distributed to three direct accounts in NM, AZ and UT.
Code Information
1064081
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0371-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026