Class II · Moderate risk Terminated
Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceuticals USA…
Reason Lack of Assurance of Sterility
Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Crystallization: Presence of particulate matter identified as API crystallization
What was recalled
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
- Recalling firm
- Ingenus Pharmaceuticals Llc
- NDC code
- 50742-464-50
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0146-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Leucovorin recalls
See all
Class II · Moderate risk Terminated
Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
LEUCOVORIN 15MG 24; NDC/UPC 54449810; RX; TABLETS
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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