KETOROLAC TROMETHAMINE Recall D-1354-2022
Description: Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01
KETOROLAC TROMETHAMINE Recall D-1354-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1354-2022 |
| Event ID | 90703 |
| Brand | KETOROLAC TROMETHAMINE |
| Generic Name | KETOROLAC TROMETHAMINE |
| Manufacturer | KETOROLAC TROMETHAMINE |
| Original Package? | 1 |
| Active Substance | KETOROLAC TROMETHAMINE |
| Drug Route | INTRAMUSCULAR |
| Distribution | USA Nationwide |
| Quantity | 5040 vials |
| Recall Reason | cGMP Deviations: deviations leading to potential cross-contamination. |
| Drug Classification | Class II |
| Drug Code Info | 20220824 |
| Product NDC | 0487-6232 |
| Recall Initiation Date | 20220810 |
| Report Date | 20220824 |
| Classification Date | 20220817 |
| Address | 4500 12th Street Ext West Columbia, SC 29172-3025 United States |
| Recalling Firm | Nephron Sc Inc |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 4EVE5946BQ |
| Drug Application Number | ANDA211445 |
| Structured Product Labeling (SPL ID) | cf6e2f84-03b0-7f12-e053-2995a90aac06 |
| Structured Product Labeling (SPL Set ID) | ae6c60c0-e88a-45b2-e053-2995a90ac62f |
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