Status
Terminated
Drug Enforcement D-0099-2023
Lack of Assurance of Sterility
Classification
Class II
Report Date
January 18, 2023
Termination Date
September 24, 2024
Product Information
- Product description
- Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05
- Product quantity
- 38,830 syringes
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA.
Location & Firm
- Recalling firm
- Nephron Sterile Compounding Center LLC
- Address
-
4500 12th Street Ext
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0099-2023
- Event ID
- 91450
- Recall initiation date
- January 6, 2023
- Center classification date
- January 9, 2023
- Code info
- Lot: RC2011A, Exp. 2/22/2023
- More code info
- —