WATER Recall D-0364-2023
Description: Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, SC 29172, NDC 0487-6105-01
WATER Recall D-0364-2023 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0364-2023 |
Event ID | 91767 |
Brand | STERILE WATER |
Generic Name | STERILE WATER |
Manufacturer | STERILE WATER |
Original Package? | 1 |
Active Substance | WATER |
Drug Route | INTRAMUSCULAR |
Distribution | United States |
Quantity | 325,080 vials |
Recall Reason | CGMP Deviations: Potential product carryover. |
Drug Classification | Class II |
Drug Code Info | 20230308 |
Product NDC | 0487-6105 |
Recall Initiation Date | 20230223 |
Report Date | 20230308 |
Classification Date | 20230301 |
Address | 4500 12th Street Ext West Columbia, SC 29172-3025 United States |
Recalling Firm | Nephron Sc Inc |
Initial Notification | Letter |
Unique Ingredient Identifier | 059QF0KO0R |
Drug Application Number | ANDA211222 |
Structured Product Labeling (SPL ID) | c3f4ecb1-53e1-5894-e053-2995a90ade2e |
Structured Product Labeling (SPL Set ID) | bc04a883-babc-87a6-e053-2995a90a3dfd |
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