Status
Terminated
Drug Enforcement D-0371-2024
cGMP Deviations: Products were stored outside the drug label specifications.
Classification
Class II
Report Date
March 20, 2024
Termination Date
August 14, 2024
Product Information
- 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
- Product quantity
- 70 vials
- Reason for recall
- cGMP Deviations: Products were stored outside the drug label specifications.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed to three direct accounts in NM, AZ and UT.
Location & Firm
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Address
-
9954 Maryland Drive, Deep Run Iii Ste. 4000
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0371-2024
- Event ID
- 93935
- Recall initiation date
- February 7, 2024
- Center classification date
- March 8, 2024
- Code info
- 1064081
- More code info
- —