Merck Recalls 22,000 Vials Of Cubicin After Discovering Glass Particles

 

Merck today announced that it is recalling some 22,000 vials of 500 mg CUBICIN for intravenous injection following a complaint that a piece of glass was found in one of the vials post reconstitution. 

The entire lot of CUBICIN (daptomycin), numbered 934778, which has an expiry date of June 2022, will be recalled from the user level, including administering institutions and hospitals. 

Possible initial reactions to the contaminated product could be swelling or irritation at the infusion site as part of the body’s response to having a foreign material introduced to it. Having glass particulates in IV infusions places a patient at risk for serious health consequences, including clotting and blockages in blood vessels, leading to death if it reaches a critical organ. Other repercussions could be prolonged hospitalization, especially for patients who receive the contaminated drug repeatedly over time. 

The risk for injury or morbidity can be reduced through detection, as healthcare providers are instructed to carefully inspect the vials first to spot the possible presence of particulates before infusion. As of this writing, there have been no reported adverse events concerning the recall. 

CUBICIN is a lipopeptide antibacterial drug indicated to treat skin infections in both pediatric and adult patients, as well as Staphylococcus aureus bloodstream infections (bacteremia) in adults, including those diagnosed with right-sided endocarditis. It is sold as a 10 mL glass vial that contains 500 mg of daptomycin. The entire lot had 76,163 vials, of which 21,603 had already been distributed. The product was distributed to wholesalers from June 1 to September 9, 2021, in the United States. 

Source: BioSpace

“Our highest priorities are the health and safety of patients and the quality of our medicines and vaccines. We sincerely regret any inconvenience caused by this recall,” said Richard M. Haupt, M.D. Ph.D., vice president and head of the vaccines & infectious diseases unit at Merck Research Labs, in a statement. 

Merck is notifying customers and distributors to arrange the withdrawal of the lot from public hands. All Merck direct consignees are instructed to conduct a sub-recall and inform their customers to whom they distributed the affected vials. 

Meanwhile, patients who already have the vials on hand are advised to contact Sedgwick at (877) 830-9730 for return instructions and to call their doctors if they experience any adverse reactions to taking the drug. Sedgwick will be the one to provide complainants with packing slips, prepaid shipping labels, business reply cards to facilitate the return. 

Patients may also report adverse reactions to the U.S. Food and Drug Administration’s MedWatch Adverse Event Reporting program.

 

BioSpace source:

https://www.biospace.com/article/merck-recalls-22-000-vials-of-cubicin-after-discovering-glass-particles-in-vials