Reported Oct 23, 2019 · Terminated
Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus…
Ingenus Pharmaceuticals LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ingenus Pharmaceuticals Llc · 4190 Millenia Blvd · Orlando, FL · 32839-6408
Is this the product you have?
- 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
- Lot codes and dates
Lot#: 1804818049 Exp. 04/202018050 Exp 05/202019036 Exp 12/2020
- Amount recalled
- 16485 vials
Where it was sold
- Nationwide
Why it was recalled
Crystallization: Presence of particulate matter identified as API crystallization
This product could cause temporary or reversible health problems — stop using it.
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