AI accountability, faster FDA pathways, rare disease CMC review, and next-gen GLP-1 formulation lead this week’s PharmTech roundup.
News|Articles|July 31, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
- PTSM: Pharmaceutical Technology Sourcing and Management-08-05-2015
- Volume 11
- Issue 8
Silicone Rubber Pieces Spur Recall of Teva Product
Author(s)Pharmaceutical Technology Editors
Teva Parenteral Medicines initiates voluntary nationwide recall of select lots of Adrucil due to particulate matter.
Advertisement
Teva Parenteral Medicines announced on July 24, 2015 a voluntary recall of six lots of Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of particulate matter identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected, according to a recall notice on the FDA website. To date, Teva has not received any reports of adverse events related to this recall.
Adrucil Injection is used in the palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas and is packaged in pharmacy bulk packages. Teva has distributed this product nationwide through wholesalers, retailers, and pharmacies.
Teva has notified its direct customers by mail and has issued an Urgent Drug Recall Letter.
Source:
Articles in this issue
about 11 years ago
CDMOs Move Slowly with Expansion Plansabout 11 years ago
Accelerating Continuous API Synthesisabout 11 years ago
BioOutsource Opens New Facility in Glasgowabout 11 years ago
Baxter Recalls IV Solution for Container and Particulate Issuesabout 11 years ago
Indian API Manufacturer Cited for Recordkeeping Failuresabout 11 years ago
Xcelience Makes Investment in Powdersizeabout 11 years ago
FDA Issues Quality Metrics Draft Guidance Document for Commentabout 11 years ago
EMA Issues Guideline on Fast Tracking Drugs for Unmet Needsabout 11 years ago
SafeBridge Updates Potent API and Drug Manufacturer StatusAdvertisement
Related to this article
Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
Richard Jaenisch explains what FDA's real-world use case database means for CMC and quality teams navigating NAMs.
This article examines how modern automation platforms create the digital foundation required for Pharma 4.0 by integrating manufacturing systems, centralized data management, Industrial Internet of Things connectivity, electronic batch production records, and AI-driven analytics.
This week, drug formulation and manufacturing experts showcased their knowledge, and companies exhibited their products, at CPHI Milan.
FDA approves Teva’s Weltruza, a once-monthly subcutaneous olanzapine for schizophrenia whose copolymer depot eliminates post-injection monitoring.
Mitigating nitrosamine risk requires assessing each product individually, says Bram Baert, Global Head of Regulatory Affairs at Capsugel, and Sandrine Picco, Senior Analytical Specialist on Capsugel's Innovaform Accelerator Team, in this interview with PharmTech.
This week on PharmTech, Merck diversified its pipeline, USP emphasizes supply chain security, AI systems are examined, and speakers preview their presentations at CPHI Milan and AAPS PharmSci 360.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
Formulation Strategies for Next-Generation Multiagonists
2
NVIDIA’s $250M Agentic AI Safety Bet: What GMP Gains
3
Manufacturing Intelligence: What FDA's Real-World Use Case Database Means for CMC
4
MASH and Cardiomyopathy Targets: Why AstraZeneca Chose insitro’s AI
5