“Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death.”
On March 12, 2024, Par Pharmaceutical, Inc. voluntarily recalled one lot of Treprostinil Injection due to the potential presence of silicone particulates in the product solution. The recall occurred just weeks before the product’s expiration in April 2024, underscoring the importance of pulling potentially harmful products from the market, regardless of how close they are to expiry. Despite being distributed nearly two years ago, no adverse events related to the recall have been reported to date. This decision reflects a commitment to quality that the pharmaceutical industry can learn from: ensuring patient safety always takes precedence.
Silicone can find its way into drug products in several ways, as it plays a vital role in drug containers like syringes and vials. Here’s why silicone is commonly used:
- Lubrication: Silicone allows for smooth movement of the syringe plunger, making drug administration easier.
- Sealant: It acts as a sealant, ensuring sterility and preventing contamination by keeping air and particles out.
- Reduced Friction: Silicone reduces friction between rubber stoppers and containers, minimizing wear during handling and use.
- Non-reactive: Silicone’s chemical inertness prevents it from reacting with most drugs, making it a safe choice for packaging.
While these properties make silicone essential in pharmaceutical packaging, excess amounts can lead to contamination with visible particulates, posing a risk to patient safety. This emphasizes the critical nature of visual inspection processes, which are designed to identify particulate contamination before products reach the market. Additionally, incorporating particulate specifications during stability testing is crucial for ensuring that drug products remain safe and particle-free until their expiration.
Conclusion
The Treprostinil recall serves as a reminder that silicone, though commonly used, must be controlled to prevent similar incidents. By learning from this recall and implementing mitigation strategies, the pharmaceutical industry can continue to safeguard the quality and safety of injectable products.
For the most up-to-date and accurate information on drug product recalls, please visit the FDA’s official website at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
