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#: 18048
    • 18049 Exp. 04/2020
    • 18050 Exp 05/2020
    • 19036 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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Ingenus Pharmaceuticals LLC recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 1, 2020 · Data as of Sep 19, 7:12 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.