Drug product
Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839
D-0146-2020
Product summary
- Event
- Event 84011
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16485 vials
- Official record key
drug-enforcement:D-0146-2020
Official wording
Reason: Crystallization: Presence of particulate matter identified as API crystallization
Code information: Lot#: 18048, 18049 Exp. 04/2020; 18050 Exp 05/2020; 19036 Exp 12/2020
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Foreign material or chemical contamination
particulate matter