Product Sterility Concerns Prompt Recall of Certain Pain Medications

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Several pain medications are among those listed on a voluntary product recall list recently issued by Pharmakon Pharmaceuticals, Inc.

According to a prepared statement from Pharmakon officials, they are voluntarily recalling all lots of sterile products aseptically compounded due to the Food and Drug Administration's (FDA) concern over a lack of sterility assurance and other quality issues. Although there have been no reports of adverse events or injuries to date, company officials note that "administration of a sterile drug product intended to be sterile that is compromised may result in serious and potentially life-threatening infection."

These compounded sterile products are used for a variety of indications, including several pain-related medications, and are packaged in bags, syringes and cad cassettes. All recalled products have a label that includes the Pharmakon Pharmaceuticals, Inc. name, address and expiration date. The sterile products were distributed nationwide to hospitals between March 4, 2016 and April 15, 2016.

All hospitals that received sterile compounded products from Pharmakon Pharmaceuticals, Inc. between March 4, 2016 and April 15, 2106 and that remain within expiry, are being urged to take the following actions:

  1. Discontinue use of the products.
  2. Quarantine any unused product.
  3. Contact Pharmakon Pharmaceuticals, Inc. at 888-660-6715 x 251 Monday-Friday to discuss the return of any unused sterile compounded products.

Customers with questions can contact Pharmakon Pharmaceuticals, Inc. by phone 888-660-6715 or email at contactmfg@pharmakonrx.net.

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm.

The entire Voluntary Product Recall List can be found at: https://pharmakonmfg.net/pr/.

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