Product: Drugs Recipient: AceCosm Hong Kong SAR China Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER November 3, 2025 AceCosm: This […]

Action The U.S. Food and Drug Administration (FDA) has approved Linzess (linaclotide) capsules for pediatric patients 7 years and older with irritable bowel syndrome with constipation […]

Product: Drugs Recipient: onlineotcmeds.com United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States FROM: The United States Food and Drug Administration RE: […]

Delivery Method: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED Reference #: 320-26-02 Product: Drugs Recipient: Recipient Name Ms. Denise Kwiatkowski Recipient Title Regulatory Affairs Manager Scientific Protein […]

Delivery Method: VIA UPS Reference #: 320-26-12 Product: Drugs Recipient: Recipient Name Mr. Allan Oberman Recipient Title President & Chief Executive Officer Apotex Inc. 150 Signet […]

Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Reference #: 320-25-113 Product: Drugs Recipient: Recipient Name Ms. Treasure Holston Recipient Title Chief Executive […]

Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Reference #: 320-26-06 Product: Drugs Recipient: Recipient Name Mr. James Daniel Bailey Recipient Title Site/Plant […]

On This Page Date: December 16, 2025 Time: 9:00 a.m. – 4:30 p.m. ET Location: Event Location Duke in DC OfficeConference Center 1201 Pennsylvania Ave. NW, […]

Summary Company Announcement Date: October 31, 2025 FDA Publish Date: November 03, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential for Potassium chloride […]