Sagent Recalls One Lot of Antibiotic
Sagent Pharmaceuticals has announced a voluntary nationwide recall of one lot of oxacillin for injection, USP, 10 g, manufactured by Astral SteriTech Private Limited and distributed by Sagent. Sagent has initiated this voluntary recall to the user level due to the receipt of a product complaint for a single vial containing small, dark particulate matter found within the solution after reconstitution. The particulate matter has been identified as iron oxide.
In the event that metal particulate in an injectable product is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, or blockage of blood vessels. To date, Sagent is not aware of any known adverse patient events resulting from the use of the subject product lot.
The lot number being recalled is Lot OXT512, which was distributed to hospitals, wholesalers and distributors nationwide from June 2016 through July 2016. Oxacillin for injection, USP, 10 g is indicated in the treatment of infections caused by penicillinase-producing Staphylococci, which have demonstrated susceptibility to the drug. It is available by prescription only.
This follows an earlier recall that the company implemented for the same product in June 2016.