PharMEDium: Cease and Desist Issued
The product liability attorneys at The Law Offices of Peter Angelos are dedicated to providing consumers with information regarding the latest pharmaceutical safety notifications and recalls.
On March 1, 2018 PharMEDium Services LLC was issued a 30-day cease and desist order from the California Board of Pharmacy following an investigation which indicated noncompliance with state regulations and federal good manufacturing practices. PharMEDium Services, LLC’s Sugarland, TX non-resident outsourcing facility was inspected by the board, which issued a report with findings on Oct. 11, 2017.
Who is PharMEDium?
PharMEDium Services, LLC specializes in the production and distribution of pharmacy-outsourced, ready-to-use compounded sterile preparations (CSPs). The company has produced and supplied compounded sterile preparation products for over 20 years, including products such as syringes, IV bags, cassettes, PCA vials and elastomeric pumps. PharMEDium products are used in various healthcare facilities such as intensive care units (ICU) and emergency rooms (ER). PharMEDium’s ready to use products are designed to allow clinicians ease of use and preparation so that they may focus on other important aspects of complete patient care such as the wellbeing of the patient.
What is the Issue?
PharMEDium was issued a 30-day cease and desist order by the California Board of Pharmacy following an investigation of their Sugarland facility located in Texas. The investigation findings, released on October 11th, 2017 detail that sterile drug products failed to meet good manufacturing practice standards and lacked assurance of sterility. Although PharMEDium responded to the findings with an action plan, it has failed to remedy 14 areas of non-compliance.
The 30-day cease and desist order effectively prevents sterile and non-sterile drug product shipments into California for 30 days or until the date of a hearing seeking an interim suspension order, whichever is earlier.
Previous Recalls
PharMEDium had previously issued a voluntary recall on additional lots of sterile drug products to the hospital and user level due to a lack of assurance of sterility. The original recall included a total of 55 lots of different products impacting 25,327 units. The expanded recall includes all lots within expiry compounded at the Memphis, TN facility.
A list of the latest recalls can be found here.
Recommendations
Healthcare professionals have been advised to discontinue the administration and quarantine any of the PharMEDium products on the recall list. Although to date PharMEDium has not received any reports of adverse events related to the products, the administration of contaminated drugs may lead to life threatening injury or death. Patients who have received any drug product produced by PharMEDium, and have concerns about their health, should contact their health care provider.
Have You Been Affected by a Pharmedium Product?
If you have suffered injury after using any pharmaceutical products manufactured by PharMEDium Services, it is important that you speak with your medical provider as to any necessary steps to ensure your health and safety. You should also file a report with the FDA through the Administration’s Adverse Event Reporting System. For more information, or to speak with an experienced attorney about your specific claim, contact the product liability attorneys at the Law Offices of Peter Angelos today.