PHYTONADIONE Recall D-0007-2023
Description: Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16
PHYTONADIONE Recall D-0007-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0007-2023 |
| Event ID | 90868 |
| Brand | PHYTONADIONE |
| Generic Name | PHYTONADIONE |
| Manufacturer | PHYTONADIONE |
| Original Package? | 1 |
| Active Substance | PHYTONADIONE |
| Drug Route | INTRAMUSCULAR |
| Distribution | USA nationwide |
| Quantity | 2,838 ampules |
| Recall Reason | Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content. |
| Drug Classification | Class III |
| Drug Code Info | 20221012 |
| Product NDC | 43598-405 |
| Product NUI | N0000175965 N0000175982 M0022806 |
| Pharma Class (PE) | Increased Prothrombin Activity [PE] |
| Pharma Class (EPC) | Vitamin K [EPC] |
| Pharma Class (CS) | Vitamin K [CS] |
| Recall Initiation Date | 20220914 |
| Report Date | 20221012 |
| Classification Date | 20221006 |
| Address | 107 College Rd E Princeton, NJ 08540-6623 United States |
| Recalling Firm | Dr. Reddy's Laboratories, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | A034SE7857 |
| Drug Application Number | ANDA207719 |
| Structured Product Labeling (SPL ID) | c4a2bf44-0ad2-c0d2-164f-562ba6df930c |
| Structured Product Labeling (SPL Set ID) | 02445c07-7b4b-cd70-54e8-ebefc814f547 |
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