Argatroban Injection has been recalled for contamination by its supplier, Eagle Pharmaceuticals Inc., said the U.S. Food & Drug Administration (FDA).
The nationwide recall involves all four lots of Argatroban Injection, 50 mg per 50 mL—NDC number 42367-203-07 (single unit) NDC number 42367-203-84 (10 pack)—and was implemented due to a potential for visible particulates. The recall is being conducted at the wholesaler, pharmacy, and distributor level.
During the investigation of the only product complaint, a visible particulate was discovered in a stability sample in one of the distributed lots. This led to a re-inspection of undistributed lots at the manufacturing site. The re-inspection revealed a small number of visible particulates in several vials.
The potential presence of visible particulates creates a risk of embolization/infarction to organs, with potential organ complications. The Medicines Company sells Argatroban Injection.
To date, no reports of adverse events have been received by The Medicines Company related to this issue.
Eagle Pharmaceuticals Inc. has directed The Medicines Company to arrange for the return of the following lots from all services and facilities:
- • Lot V10189; expiration date January 2013
- • Lot V10191; expiration date January 2013
- • Lot V10194; expiration date January 2013
- • Lot V10223; expiration date February 2013
MedicineNet explained that Argatroban is a blood thinner used in some procedures to prevent blood clots and to open up the blood vessels in the heart during, for instance, balloon angioplasty, coronary stent placement, or percutaneous coronary intervention-PCI. Argatroban is typically with aspirin and is also used to treat and prevent harmful blood clots and increase platelets in patients with a reaction to heparin known as heparin-induced thrombocytopenia-HIT).
Argatroban works by blocking the natural substance thrombin, which is used by the body to form blood clots or can cause an opened blood vessel in the heart to close back up, said MedicineNet.
The Medicines Company can be reached, toll-free, at 1.888.977.6326 or by email at email@example.com.
Any adverse events that may be related to the use of this product should be reported to The Medicines Company or to FDA’s MedWatch Program, either online, by regular mail, or by fax. FDA’s MedWatch Program can be accessed online at www.fda.gov/medwatch/report.htm; by regular mail by using the postage-paid, pre-addressed Form FDA 3500 that is available at www.fda.gov/MedWatch/getforms.htm and which should be mailed to the address on the pre-addressed form; or by toll-free fax to 1.800.FDA.0178.