Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility
Leucovorin Calcium Injection
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
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
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
Affected NDC
50742-0464-50
Compare with the code on your package — it is the most precise check available.
Drug: Leucovorin
- 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 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Leucovorin recalls
See all
Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Leucovorin Calcium for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Leucovorin 15mg 24
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other recalls by Ingenus Pharmaceuticals Llc
All 2019 recalls
Class II · Moderate risk
Flunisolide Nasal Solution
Out of specification for related substances (impurities).
Class II · Moderate risk
Clobetasol Propionate Foam
CGMP Deviations
Class III · Low risk
Diclofenac Sodium Topical Solution
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
Class II · Moderate risk
Irinotecan Hydrochloride Injection
Superpotent Drug: High out of specification assay value results for potency.
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