Last Updated on October 26, 2021 by The Health Master
Merck is voluntarily recalling one lot of CUBICIN® (daptomycin for injection) 500mg for intravenous use, Lot 934778, Exp June 2022.
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.
Approximately 22,000 vials are affected by this recall. The recall has been initiated following receipt of a customer complaint reporting that a piece of glass was found in a vial of CUBICIN after reconstitution.
There were 76,163 total vials manufactured in the affected lot; and of those vials, 21,603 have been distributed. The affected CUBICIN lot includes the following: Bulk drug product and packaged lot 934778, expiration date June 2022. This product was distributed to wholesalers between June 1, 2021, and Sept. 9, 2021, in the U.S.
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of glass particulates has the potential to cause serious health consequences if the particulate is small enough to be withdrawn from the vial and infused into the patient.
Local irritation or swelling at the infusion site may occur in response to the presence of foreign material. More serious potential outcomes include blockage and clotting in blood vessels, which can be life-threatening if a critical organ is affected.
Other clinical consequences could include prolonged hospitalization, particularly in those patients receiving an extended treatment regimen for which multiple vials of CUBICIN are administered over the course of treatment.
The risk is reduced by the possibility of detection, as the label contains a clear statement directing the healthcare professional to visually inspect the product for particulate matter prior to administration. To date, Merck has not received any reports of adverse events related to this recall.
Drug recall: Glenmark, Aurobindo recall multiple products
Auro Pharma recalls batches of Drug used to treat severe disease
Drug recall: Granules India and Jubilant recall these Drugs
Drug recall: Dr Reddy’s & Zydus Pharma Recall these drugs
Drug Recall: Metformin oral solution batch due to nitrosamine impurity
J&J recalls these Sunscreens after carcinogen found in some sprays
Drug to treat Dengue developed, DCGI nod for trial
Pharma companies rely on Optical Sensor Packaging & Labelling
USFDA approval for J&J and Moderna C-19 booster dose
Australia can be Major Partner for Indian Pharma Companies
Surgeons successfully test Pig Kidney transplant in human patient
Indian Nutraceutical industry now a days
Latest Notifications regarding Pharmaceuticals
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: