Recall D-1278-2022
Description: Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Injection, 50 mL syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-515-50
Recall D-1278-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-1278-2022 |
Event ID | 90512 |
Distribution | Nationwide in the USA |
Quantity | 2210 syringes |
Recall Reason | Lack of Assurance of Sterility |
Drug Classification | Class II |
Drug Code Info | 20220727 |
Recall Initiation Date | 20220630 |
Report Date | 20220727 |
Classification Date | 20220718 |
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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