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
D-0371-2024
Product summary
- Event
- Event 93935
- Status
- Terminated
- Classification
- Class II
- Quantity
- 70 vials
- Official record key
drug-enforcement:D-0371-2024
Official wording
Reason: cGMP Deviations: Products were stored outside the drug label specifications.
Code information: 1064081
Distribution pattern: Product was distributed to three direct accounts in NM, AZ and UT.
Derived failure modes
-
Manufacturing or process control
cGMP Deviations