Reason for Announcement: Out-of-Specification (Failed Assay) in the Laboratory Analyses
Marketing Authorization Holder (MAH): Seapharma International, Inc.
Product Description: Enalapril Maleate 10 mg and 20 mg Tablets (Prilsea 10 & Prilsea 20)
Registration Number: DRP-6090 & DR-XY44331
The stated MAH released their media announcement (see attached) on their voluntary recall of the aforementioned drug products. The said press release was also uploaded in their official website/account at https://www.facebook.com/112180080343640/posts/114987580062890/?d=n.
For more information and inquiries, please e-mail us at [email protected]. To inform us on the continuous sale or distribution of recalled health products, kindly report through the online reporting facility, eReport, at http://www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.
Dissemination of the information to all concerned is requested.
Attachment:-> Media Announcement-Prilsea 10 and Prilsea 20