Recall D-0099-2023
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
Recall D-0099-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0099-2023 |
Event ID | 91450 |
Distribution | Nationwide in the USA. |
Quantity | 38,830 syringes |
Recall Reason | Lack of Assurance of Sterility |
Drug Classification | Class II |
Drug Code Info | 20230118 |
Recall Initiation Date | 20230106 |
Report Date | 20230118 |
Classification Date | 20230109 |
Address | 4500 12th Street Ext West Columbia, SC 29172-3025 United States |
Recalling Firm | Nephron Sterile Compounding Center LLC |
Initial Notification | Letter |
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