Hospira initiates recall after glass found in antibiotic vials

04-Jan-2023 - Last updated on 04-Jan-2023 at 21:23 GMT

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The US Food and Drug Administration (FDA) announced that Hospira had initiated the recall during the last few days of 2022. The recall extends to just one batch of the vancomycin hydrochloride injection, USP, 1.5 g/vial single dose fliptop vial product.

It was revealed that the recall was begun after two visible glass particulates were observed in a single vial of the product. The FDA stated that Pfizer had not received any reports of adverse events related to the recall.

Pfizer has notified consignees by letter to arrange for return of any recalled product, the release stated​.

Should a patient receive an injection with glass particulates intravenously, the possible adverse events include minor issues, such as local irritation or swelling, but also more serious events, such as microvascular obstruction, including pulmonary embolism. If the product were administered orally or via a nasogastric tube, there would be the potential for gastrointestinal trauma.

The agency outlined that the risk of such adverse events could potentially be mitigated through inspection by the healthcare professional tasked with delivering the product. According to the FDA, the label contains a statement that directs healthcare professionals to visually inspect the product for particulate matter, such as glass, and discoloration prior to administration.

Vancomycin hydrochloride is an antibiotic indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant staphylococci. The antibiotic can be used where patients are allergic to penicillin, and for patients who have not responded to other antimicrobials.

This incident was not the first time in 2022 that Hospira needed to issue a voluntary recall.

In August, the company recalled one lot of propofol injectable emulsion, after visible particulates were observed in two vials.

The month prior, the company issued another voluntary recall after finding visible particulate in the same product, but in a different lot. The product in question is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation.

Pfizer acquired Hospira in 2015, but has faced intermittent regulatory challenges related to manufacturing since that time. Over the years, this also had an impact on the financials​ of the parent company, and coincided with the closure of several of the plants that were originally added by the acquisition.

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