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Mylan’s EpiPen Recall: Another Hit On The Auto-Injector

 
• By Sue Sutter

What began as an overseas recall of one lot made by a Pfizer subsidiary is expanding, threatening to besmirch Mylan’s once golden supply-chain quality record. The recall follows pricing controversy around the EpiPen product got the CEO hauled before Congress.

A newly expanded recall of Mylan NV’s epinephrine auto-injector EpiPen shows that even a company that has long prided itself on supply chain quality is not immune from a high-profile recall due to manufacturing issues.

On March 31, FDA and Mylan announced the US expansion of a recall that was initially limited to several foreign...

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More from Combination Products

Injuries And Deaths Linked To Baxter Infusion Pump

 
• By Brian Bossetta

The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.

Novel Pathway For Combined Drug/IVD Trials Wins Backing Of EU Nations

 
• By Vibha Sharma

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.

New Draft Guidance Clarifies FDA’s UDI Rules For Combination Products

 
• By Elizabeth Orr

The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products. The document specifies labeling requirements and makes recommendations to reduce confusion between UDIs and NDCs. Comments are being accepted until Sept. 24.

European Commission Asks For ‘Open Minds’ On Unified Drug/Device Research Pathway

 
• By Vibha Sharma

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

More from Device Area

FDA Panel Supports Dermal Fillers For Décolletage Use

 
• By Elizabeth Orr

An FDA panel has endorsed the use of dermal fillers for décolletage, but warned of patient safety concerns. The filler can cause complications with future imaging and pregnancy or breastfeeding, panelists said. Regulatory measures and patient studies are recommended for better outcomes.

After Thought-Control Demo, Synchron Plans Pilot Study With Upgraded BCI On Path To Pivotal Trial

 
• By Marion Webb

Synchron is preparing a pilot study of its fully wireless, second-gen brain-computer interface after an ALS patient controlled an iPad solely by thought. If all goes as planned, Synchron’s BCI will move into pivotal trials in 2026.

Apreo Health Raises $130M, First Patient Treated In US Clinical Trial

 
• By Natasha Barrow

Apreo Health CEO Karun Naga talks to Medtech Insight about the company’s intentions for its Series B funding. The Breathe-3 clinical trial and early commercialization activities, involving physician education, are top priorities.