Accupack Midwest, Inc. – 680228 – 08/15/2024
CGMP/Finished Pharmaceuticals/Adulterated
-
-
Media Networks Sydney Pty Limited – 687044 – 09/18/2024
Failure to Register and List -
Aerosol and Liquid Packaging, Inc. – 676746 – 07/24/2024
CGMP/Finished Pharmaceuticals/Adulterated -
Nomida.biz – 687590 – 09/12/2024
Unapproved New Drugs/Misbranded -
Azurity Pharmaceuticals, Inc. – 656489 – 09/20/2024
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug -
Ultra Seal Corporation – 624650 – 09/25/2024
CGMP/Finished Pharmaceuticals/Adulterated -
Conducting Remote Regulatory Assessments Questions and Answers
Conducting Remote Regulatory Assessments Questions and Answers Guidance for Industry -
Biosimilar Product Information
This page includes a chart of the approved biosimilar and interchangeable products. The approval of biosimilar products can improve access to care for patients by increasing the number of medication options and potentially lower costs. -
Class 3 Medicines Recall: Tamoxifen 20mg Film-Coated Tablets, Wockhardt UK Ltd, EL(25)A/31
Wockhardt UK Limited is recalling a batch as a precautionary measure following the identification of a dissolution failure during stability testing.
-
Types of application for marketing authorisations (legal basis of applications)
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
-
Class 3 Medicines Recall: Omeprazole 20 mg/15 ml Oral Solution, Glenmark Pharmaceuticals Europe Ltd, EL(25)A/30
Glenmark Pharmaceuticals Europe Ltd is recalling a specific batch of Omeprazole Oral Solution as a precautionary measure due to an investigation following a customer complaint indicating precipitation and discoloration of the product in the bottles.
-
Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging
Sandoz, Inc. (“Sandoz”) is initiating a voluntary recall of one (1) lot of Cefazolin for Injection, USP, 1 gram per vial.