Guidance: Herbal medicines granted a traditional herbal registration (THR)
A list of herbal medicines currently holding a traditional herbal registration (THR) granted by the Medicines and Healthcare products Regulatory Agency (MHRA).
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Class 2 Medicines Recall: Baxter Healthcare Limited, Compound Sodium Lactate Solution for Infusion BP (Hartmann’s Solution for infusion) in Viaflo 1000ml, EL(25)A/46
Baxter Healthcare is recalling one batch of Compound Sodium Lactate (Hartmann’s Solution) 1000mL. This is due to a packaging error where some cartons labelled as Hartmann’s Solution may contain Ringer’s Solution 1000mL.
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Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development – 05/29/2024
Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development -
Zingerman’s Candy Manufactory Issues Allergy Alert on Undeclared Peanut & Cashew in Candy Bars
Zingerman’s Candy Manufactory of Ann Arbor, Michigan is recalling Zingerman’s Peanut Butter Crush Full Size Bars with Lot#174250 because it may contain undeclared cashew and Zingerman’s Ca$hew Cow Full Size Bars with Lot#174250 because it may contain undeclared peanut. People who have an allergy or -
Peterson Company Recalls Twin Sisters Creamery Brand Whatcom Blue and Farmhouse Cheese Products Because of Possible Health Risk
October 26, 2025, Peterson Company of Auburn, WA is voluntarily recalling Twin Sisters Creamery brand item# 28855 Whatcom Blue and item# 29608 Farmhouse Cheese products which were made from raw milk because they may be contaminated with Shiga toxin-producing -
Dr. Reddy’s Laboratories, Mirfield, West Yorkshire, UK 9.1-9.5.25_483
Record Date: 09/05/2025
Entity Name: Dr. Reddy’s Laboratories (EU) Ltd.
FEI Number: 3002807544
Record Type: 483
Country: United Kingdom
Establishment Type: API Manufacturer -
Endo Expands Voluntary Recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Due to Potential Product Carton Strength Mislabeling
Endo, Inc. (OTCQX: NDOI) (“Endo”) announced today that one of its operating subsidiaries, Endo USA, Inc., is expanding its previously announced voluntary recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential product carton strength mislabeling. -
Research: Report of The Commission on Human Medicines Isotretinoin Implementation Advisory Expert Working Group
Report of Isotretinoin Implementation Advisory Expert Working Group regarding recommendations to strengthen the safe use of isotretinoin, the acne medicine commonly known by brand names Roaccutane and Reticutan.
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Isotretinoin – updates to prescribing guidance and survey of services
The Commission on Human Medicines (CHM) has endorsed changes to isotretinoin prescribing guidance. In addition, CHM is seeking further information from dermatology services who prescribe isotretinoin to inform any future changes to current risk minimisation measures.
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Completed BsUFA III Deliverables
Since the passage of the Biosimilar User Fee Act (BsUFA) in 2012, user fees have played an important role in expediting the process for the review of biosimilar products. -
Sumitomo Pharma Co., Ltd. 8/7/2025 483
Record Date: 08/7/2025
Entity Name: Sumitomo Pharma Co., Ltd.
FEI Number: 3003028650
Record Type: 483
Country: Japan
Establishment Type: Drug Manufacturer -
Hetero Labs Limited Warehouse 483 – 9/26/25
Record Date: 09/26/2025
Entity Name: Hetero Labs Limited (Warehouse)
FEI Number: 3040501127
Record Type: 483
Country: India
Establishment Type: Warehouse