Regulatory Affairs

Urgent: Ocumont Eye Ointment Recall Due to Missing Braille Labeling

Meta description: Blumont Pharma Limited issues recall for Ocumont Eye Ointment due to missing Braille labeling on outer cartons. Published…

MHRA Issues Latest Safety Roundup for January 2026: Key Updates for Medical Device Users

Published on 2026-01-27T22:01:44.000Z, the Medicines and Healthcare products Regulatory Agency (MHRA) has released its latest safety roundup, highlighting crucial updates…

Recent Field Safety Notices: Updates from 19 to 23 January 2026

As of 27 January 2026, several field safety notices have been issued, affecting various medical devices. These notices are crucial…

Swissmedic Approves Extension of Therapeutic Indication for Hepcludex

On January 27, 2026, Swissmedic announced the extension of the therapeutic indication for Hepcludex, a medication used to treat a…

Mercury Pharmaceuticals Ltd Issues Precautionary Recall of Paliperidone Pre-Filled Syringes Due to GMP Deficiencies

Published on 2026-01-26T18:30:14.000Z, a significant recall alert has been issued by Mercury Pharmaceuticals Ltd. The company is recalling the remaining…

Glenmark Pharmaceuticals Europe Limited Issues Precautionary Recall of Fingolimod Glenmark 0.5 mg Hard Capsules

Meta description: Glenmark Pharmaceuticals Europe Limited recalls Fingolimod Glenmark 0.5 mg Hard Capsules due to stability testing issues. Published on…

Medical Device Field Safety Notices Issued from 12 to 16 January 2026

As of 22 January 2026, a series of field safety notices were issued for medical devices used in various clinical…

Olympus Expands Recall of ViziShot 2 FLEX Needles Over Patient Safety Concerns

January 17, 2026 OLYMPUS CORPORATION has expanded its global medical device removal action for ViziShot 2 FLEX (19G) EBUS-TBNA needles,…

Swissmedic Expands Indication for Amvuttra

Published January 26, 2026 The Swiss Agency for Therapeutic Products (Swissmedic) announced an extension of the therapeutic indication for Amvuttra,…

Swissmedic Introduces New Requirements for Integral Combination Products

On January 21, 2026, Swissmedic announced new requirements for the authorization of medicinal products with integral medical device components, also…

Swissmedic Batch Recall of Risperidon-Mepha LA Injection

What Changed? As of January 22, 2026, Swissmedic announced a batch recall of Risperidon-Mepha LA Pulver und Lösungsmittel zur Herstellung…

Breaking Swissmedic News: Critical Quality Issue with Arixtra® Fondaparinux Sodium Prefilled Syringe Needles