Leucovorin Calcium Injection Recalled due to Potential Health Hazard from Visible Particulate Matter

Pharmacy, Risk Manager and Oncology Health professionals are informed by the FDA that Leucovorin Calcium Injection is recalled because visible crystalline particulate matter has been discovered, identified as a potential hazard that may cause serious adverse events, including death.

Background of Leucovorin Calcium Injection

Leucovorin Calcium Injection, by Bedford Laboratories, is used to reduce the folic-acid-lowering side effects of methotrexate and in combination with fluorouracil to treat cancer of the colon. Moreover, it is used to treat megaloblastic anemia.

FDA Alert on Leucovorin Calcium Injection

Due to the discovery of visible crystalline particulate matter in a small number of vials of Leucovorin Calcium Injection, the affected lots are recalled as this may lead to severe adverse events including occlusion of capillaries and arteries, anaphylactic shock, severe pulmonary dysfunction, local tissue infarction, vein irritation and phlebitis, clinically occult pulmonary granulomas detected at routine autopsy examination, and death.

The affected lot are:

• Leucovorin Calcium Injection, 500mg SDV Bedford Label, NDC 55390‐009‐01
  • Lot # 2017620, with Expiration date 1/31/2013
  • Lot # 2038374 with Expiration date 2/28/2013
• Leucovorin Calcium Injection,  500mg SDV NOVA PLUS Label, NDC 55390‐826‐01, lot #2038374A with Expiration date 2/28/2013

All affected lots are in 1 pack package size.

FDA Recommendation on Leucovorin Calcium Injection

{Healthcare practitioners who had received the lot were instructed not to use the product and immediately quarantine it for return. As stated in the Product Package Insert, “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.”}

Contacting the FDA to report cases with Leucovorin Calcium Injection

In case of detection of adverse events or side effects related to the use of Leucovorin Calcium Injection, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted Online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to:  1-800-FDA-0178

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