FDAFDA · Food and drugs·Recall number D-0146-2020
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
Published October 23, 2019 · Recall initiated: October 9, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Crystallization: Presence of particulate matter identified as API crystallization
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ingenus Pharmaceuticals Llc
- Distributor
- U.S.A. Nationwide
- Lot
- Lot#: 18048, 18049 Exp. 04/2020; 18050 Exp 05/2020; 19036 Exp 12/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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