All healthcare professionals and the general public are hereby advised by the Food and Drug Administration (FDA) regarding the voluntary recall by the marketing authorization holder (MAH) on the affected lot of the subject product from the market. The details of the product are as follows:
|DRUG PRODUCT||PANITUMUMAB 20 MG/ML CONCENTRATE FOR SOLUTION FOR INTRAVENOUS INFUSION [VECTIBIX]|
|LOT NO./EXP. DATE||1153398||04 December 2024|
|MANUFACTURER||AMGEN MANUFACTURING LIMITED- United States of America|
|IMPORTER & DISTRIBUTOR||ZUELLIG PHARMA CORPORATION
– Km. 14 West Service Rd. South Superhighway, cor. Edison Ave., Sun Valley, Parañaque, Metro Manila
Panitumumab is an epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC) in combination with FOLFOX for first-line treatment and as a monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy.
The MAH pursued the voluntary recall of the drug product due to the vial seal defect issue found in a specific lot manufactured by Amgen Manufacturing Limited, USA. The vial seal defect could breach the container closure integrity which carries the potential of bacterial/microbial contamination that could lead to adverse health conditions to patients. Therefore, the stated lot presents quality and safety concerns.
Distributors, hospitals, retailers, pharmacies, or clinics that have the affected lot of the drug product are therefore instructed to discontinue further distribution, sale, and use. All consumers are likewise advised not to purchase or use the affected product lot and may contact Zuellig Pharma Corporation through [email protected] for any question or additional information regarding the recall.
All Local Government Units (LGU) and Law Enforcement Agencies (LEAs) are requested to ensure that the affected product lot is not sold or made available in their localities or areas of jurisdiction.
For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of the abovementioned, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. Any suspected adverse reaction experienced from the use of the products should be reported immediately to the FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill-out all of the required fields.
Dissemination of the information to all concerned is requested.