Recall D-0960-2022
Description: Ketamine Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 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: 69374-982-55
Recall D-0960-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0960-2022 |
Event ID | 90211 |
Distribution | Nationwide in the USA |
Quantity | 107530 syringes |
Recall Reason | Lack of Assurance of Sterility |
Drug Classification | Class II |
Drug Code Info | 20220608 |
Recall Initiation Date | 20220518 |
Report Date | 20220608 |
Classification Date | 20220527 |
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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