The Medicines Company’s supplier, Eagle Pharmaceuticals Inc., has issued a voluntary nationwide recall of all four (4) lots of Argatroban Injection, 50 mg per 50 mL (“Argatroban”) from the market due to a potential for visible particulates, according to a safety alert issued from the U.S. Food & Drug Administration, dated March 23, 2012.
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.
Eagle Pharmaceuticals Inc. is conducting this voluntary recall as a precautionary measure with the knowledge of the FDA. This voluntary recall is being conducted nationwide at the wholesaler, pharmacy and distributor levels.
During an investigation, a visible particulate was discovered in a stability sample in one of the distributed lots. Upon re-inspection, a small number of visible particulates were discovered in several vials.
The risk of using an injectable product with particulates includes embolization/infarction to organs and potential organ complications.
The Medicines Company has not received any reports of adverse events 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
The Medicines Company can be reached, toll-free, at 1.888.977.6326 or by email at argatrobanrecall@themedco.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.
