Recalls / Class II
Class IID-0099-2023
Product
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
- Affected lot / code info
- Lot: RC2011A, Exp. 2/22/2023
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Nephron Sterile Compounding Center LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4500 12th Street Ext, West Columbia, South Carolina 29172-3025
Distribution
- Quantity
- 38,830 syringes
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2023-01-06
- FDA classified
- 2023-01-09
- Posted by FDA
- 2023-01-18
- Terminated
- 2024-09-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0099-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.