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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

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 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: and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> Media Announcement-Prilsea 10 and Prilsea 20