Teva Parenteral Medicines has initiated a nationwide recall of six more lots of fluorouracil injection (Adrucil) because of the potential presence of particulate matter identified as an "aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals," the company announced July 24.
Teva recalled eight different lots of Adrucil for the same issue back in May, as reported by Medscape Medical News.
"Administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected," the company notes in a press release posted on the US Food and Drug Administration (FDA) website.
To date, the company says they have not received any reports of adverse events related to this recall.
Adrucil injection is used in the palliative management of carcinoma of the colon, rectum, breast, stomach, and pancreas. It is available in pharmacy bulk packaging containing five 5 g/100 mL vials per shelf pack.
Individual Adrucil 5 g/100 mL vials have NDC code 0703-3019-11; the pharmacy shelf pack has NDC code 0703-3019-12. The 5 g/100 mL vials are also labeled to indicate that the pharmacy bulk package is not for direct infusion. (FDA release updated July 27, 2015)
The latest recalled product was distributed throughout the United States through wholesalers, retailers, and pharmacies. The lot numbers and expiration dates are as follows:
|Lot #||Exp. Date|
Teva has sent an urgent drug recall letter to direct consumers. In addition, arrangements are being made for the affected product to be returned to Inmar, the approved return goods agent.
The company asks customers with any of the recalled lots to stop using and distributing them and to quarantine the product immediately. Customers should notify all users in their facility and notify any accounts or additional locations that may have received the recalled product.
Customers with medical questions about the recall may call 888-838-2872, option 3, then option 4. For a customer service-related question, the number is 800-545-8800, Monday through Friday, 8:00 – 5:00 ET.
Healthcare professionals are encouraged to report adverse events or adverse effects related to the use of these products to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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Cite this: Teva Recalls Six More Lots of Fluorouracil Injection - Medscape - Jul 27, 2015.