Astellas Pharma Inc. – 06/06/2025
Astellas Pharma Inc. – 06/06/2025. Country: Japan. Record Type: 483
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Class 4 Medicines Defect Notification: Flamingo Pharma UK Ltd, Amitriptyline Hydrochloride 10mg, 25mg, 50mg Tablets, EL(25)A/52
Flamingo Pharma UK Ltd has informed the MHRA that the Patient Information Leaflet (PIL) in the products listed in this notification do not contain all the required safety information.
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TBC Distribution Corporate Recalls Lucky Foods Brand Cinnamon Powder Because of Possible Health Risk
TBC Distribution Corporate of Brooklyn, NY is recalling Lucky Foods brand Cinnamon Powder 40g, best before date 15.09.2027 because it has the potential to be contaminated with elevated levels of lead. Short -
E6(R3) Good Clinical Practice (GCP)
The Food and Drug Administration is announcing the availability of a final guidance for industry entitled “E6(R3) Good Clinical Practice.” This revision incorporates flexible, risk-based approaches and embraces innovations in trial design, conduct, and technology. -
Lil’ Turtles Issues a Voluntary Recall Due to Undeclared Milk Allergen
Baltic, OH (Dec. 4, 2025) – Lil’ Turtles is recalling all lots of its Grandma Belle’s Tomato Basil Soup for misbranding due to the milk allergen not being declared on the label. The Grandma Belle’s Tomato Basil Soup was packaged in 17 oz glass jars. -
Seaway Pharma Inc. – 717355 – 12/01/2025
CGMP/Finished Pharmaceuticals/Adulterated -
CDL Services, Inc. DBA Technichem – 713877 – 11/24/2025
CGMP/Finished Pharmaceuticals/Adulterated -
DeVere Manufacturing Inc. – 715846 – 11/12/2025
CGMP/Finished Pharmaceuticals/Adulterated -
Prescription-to-Nonprescription (Rx-to-OTC) Switches
A sponsor of a nonprescription drug product may seek to market a prescription drug product as nonprescription. -
FDA Roundup: May 31, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. -
FDA Roundup: March 12, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. -
Strengthening collaboration between the MHRA and the Department of Health Northern Ireland
The MHRA and Northern Ireland partners are working together to support innovation, enhance patient safety and ensure people in Northern Ireland benefit from world-class regulation.