Concerns over lack of sterility and quality issues has prompted a recall of all sterile products aseptically compounded and packaged by Pharmakon Pharmaceuticals. These products were distributed nationwide to hospitals between March 4, 2016 and April 15, 2016.
The recall extends across numerous therapeutic categories, including products used for antimicrobial therapy and pain, as well as life-saving treatments. The products are packaged in bags, syringes and cad cassettes and have a label that includes the Pharmakon Pharmaceuticals, Inc. name, address and expiration date.
All hospitals that received these products from Pharmakon Pharmaceuticals, Inc. between March 4, 2016 and April 15, 2106 and that remain within expiry, should take the the following actions:
- Discontinue use of the products
- Quarantine any unused product
- Contact Pharmakon Pharmaceuticals, Inc. at 888-660-6715 x251 to discuss the return of any unused sterile compounded products
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program.
A complete list of affected products can be found here.