Pfizer’s Hospira Voluntarily Recalls Three Lots of Opioid Drug Over Possible Cracked Vials

By Akia Thorpe -

March 8, 2018

Hospira, a Pfizer company, is voluntarily recalling three lots of hydromorphone HCI injection, an opioid agonist for pain relief, to the hospital/institution level. Hospira initiated the recall on February 07, 2018 due to the potential that units from the lots may be empty or cracked at the bottom of the glass vial.

This recall follows an earlier voluntary recall from the company in February 2018, which Hospira initiated due to the discovery of cracks on the rim surface of vials for four lots of labetalol hydrochloride injection, a blood-pressure drug.

In a March 5, 2018 company notice posted by the US Food and Drug Administration regarding the most recent recall, the company noted that cracked vials may result in a lack of sterility assurance for the product. Hospira further noted that use of or exposure to cracked units may be associated with adverse events such as sharps injury to healthcare professionals. The notice says intravenous infusion of a non-sterile solution can lead to bloodstream infections, which may potentially lead to bacteremia or sepsis.

As of the March 5, 2018 recall notice, Hospira said it has not received reports of any adverse events associated with this issue for the three lots.

Source: FDA