Recalls / Class II
Class IID-0968-2022
Product
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL Pre-Filled Syringe, 5 x 5 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-924-05
- Affected lot / code info
- Lots: RC1050A, Exp. 5/30/2022; RC1051B, Exp. 6/6/2022; RC1053A, Exp. 6/27/2022; RC2001A, Exp. 7/19/2022; RC2002A, Exp. 8/13/2022; RC2003A, Exp. 8/28/2022; RC2004A, Exp. 9/8/2022
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, N/A, West Columbia, South Carolina 29172-3025
Distribution
- Quantity
- 604080 syringes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-05-18
- FDA classified
- 2022-05-27
- Posted by FDA
- 2022-06-08
- Terminated
- 2024-08-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0968-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.