Pfizer’s Hospira has issued a voluntary recall of three lots of the painkiller hydromorphone, an injectable, due to an apparent manufacturing issue that could lead to the glass vials being either empty or cracked.
The recall was initiated last month and is for the hospital/institution level. As part of the action, Teva also issued a subrecall of two lots of the painkiller.
In a statement posted on the FDA website, the company said cracked vials may compromise the sterility of the product, adding that it has not received reports of any adverse events associated with the recalled product. The statement did not indicate where the vials were manufactured.
Hydromorphone is an opioid used in treating severe pain for which alternative treatments are inadequate and requires an opioid analgesic. The vials were distributed nationwide to wholesalers/distributors/retailers/hospitals in the U.S. and Puerto Rico from October 2016 to July 2017.
Last month, Pfizer announced that the FDA had updated the status of its troubled Kansas fill-finish plant, which opened the path for drug approvals. However, a recently released document from the last inspection indicated some issues remained.
A Form 483 from an October 2017 inspection shows that of 10 observations the FDA noted at the plant, four were repeats from issues inspectors had seen in earlier visits. The regulatory agency’s frustration over the fact that it has pointed out similar issues at a number of Pfizer's legacy Hospira plants for years is what led the FDA to send Pfizer a scathing warning letter last year.