Pharmaceutical and medical device company is voluntarily recalling certain lots of injection products due to cracked vials
Hospira Inc., the US-based pharmaceutical and medical device company, has initiated a product recall, the US Food and Drug Administration (FDA) has announced.
According to the statement, Hospira initiated this recall on 7 February 2018 due to the potential that units from certain lots may be empty or cracked at the bottom of the glass vial.
The affected products are three lots of Hydromorphone HCl Injection, USP CII 10 mg/ml, 1 ml in 2 ml single dose vials lot numbers 71330DD (NDC 0409-2634-01), and 691853F and 700753F (NDC 0703-0110-01 – Teva lots) to the hospital and institution level.
Hydromorphone HCl Injection, USP CII 10 mg/ml, 1 ml in 2 ml single dose vials, are packaged in a carton of 10 x 1 ml single-dose vials.
Cracked vials may compromise the sterility of the product. Use of or exposure to cracked units may be associated with adverse events such as sharps injury to healthcare professionals.
The product was distributed nationwide to wholesalers, distributors, retailers and hospitals in the United States and Puerto Rico from October 2016 to July 2017.
Hospira, headquartered in Lake Forest, Illinois, has notified wholesalers, distributors, retailers, hospitals by recall letter to arrange for return of any recalled product.
Those with an existing inventory of the lots subject to this recall should stop use and distribution of the remaining units and quarantine immediately.