Merck Recall: 22,000 Antibiotic Vials Pulled Off Shelves Over Presence Of Glass Particles

Merck is voluntarily recalling one lot of its antibiotic Cubicin because it may contain glass particles. Intravenously administered glass particulates can result in potentially serious adverse effects.

The company initiated the recall after a customer notified the company about a piece of glass that was found in a Cubicin vial after it was reconstituted, an announcement posted on the U.S. Food and Drug Administration (FDA) website noted.

Cubicin is an antibiotic medicine used to treat certain bacterial infections, including "complicated" skin and skin structure infections in adult and pediatric patients aged one to 17, and Staphylococcus aureus bloodstream infections in adult patients.

"Intravenous infusion of glass particulates has the potential to cause serious health consequences if the particulate is small enough to be withdrawn from the vial and infused into the patient," the announcement read.

Possible adverse effects range from local swelling or irritation because of the foreign material, to clotting or blockage in the blood vessels. The outcome could be "life-threatening if a critical organ is affected," the company said.

Merck has not received reports of adverse reactions linked to Cubicin. It noted that the risks can be reduced by detection since the product's label has a "clear statement" instructing the healthcare professional to inspect the product for any particulate matter before administering it.

The recall affects one lot of CUBICIN (daptomycin for injection) 500mg for intravenous use. That's about 22,000 vials of Lot 934778 with an expiry date of June 2022. There were actually 76,163 vials included in the lot, but only 21,603 were distributed to wholesalers from June 1 to Sept. 9 this year, according to the company.

"Because treatment with CUBICIN is likely to be initiated at a hospital or other monitored healthcare setting, the recall is being conducted to the user level, including hospital and administering institutions," the company noted.

"Our highest priorities are the health and safety of patients and the quality of our medicines and vaccines," the vice president and head of vaccines and infectious diseases at Merck Research Labs, Richard M. Haupt, said in the news release. "We sincerely regret any inconvenience caused by this recall."