FDA MedWatch - Tri-Coast Pharmacy Sterile Products: Recall - Lack of Sterility Assurance

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Tri-Coast Pharmacy Sterile Products: Recall - Lack of Sterility Assurance

AUDIENCE: Pharmacy

ISSUE: Tri-Coast Pharmacy Inc. is voluntarily recalling all sterile products prepared between May 17, 2016 and November 17, 2016 and that remain within expiry due to FDA concerns over the lack of sterility assurance of the drugs named in this recall.

Administration of a drug product intended to be sterile that has microbial contamination has the potential to result in serious infections which may be life-threatening. No portion of any lot of these medications has been found to be non-sterile, but the FDA is concerned that the conditions under which they were produced introduce a lack of sterility assurance for these products.

See the press release for a list of affected products.

BACKGROUND: The recalled drug products were used for a variety of indications. All recalled products have a Tri-Coast Pharmacy Inc. label that includes the name Tri-Coast Pharmacy Inc., the logo, the drug name, lot number and the expiration date.

RECOMMENDATION: All patients and providers that received any sterile compounded products from Tri-Coast Pharmacy Inc. prepared between May 17, 2016 and November 17, 2016 and that remain with expiry, should take the following actions:

• Quarantine any unused product until further instruction are received to facilitate the product being returned to Tri-Coast Pharmacy Inc.
• Discontinue the use of any products contained in the recall
• Please contact Tri-Coast Pharmacy Inc at 1 (561) 776-7510 or toll free 1 (877) 823-3284, Monday through Friday, 10am to 6pm EST. or email at pharmacist@tricoastrx.com to discuss the returning of any unused product associated with this recall.

Patients should contact their physician or healthcare provider if they have experienced any problems that may be associated with using these products. Providers who have dispensed any sterile products prepared between May 17, 2016 and November 17, 2016 to a patient should contact the patient(s) to whom the product was dispensed and make the patient(s) aware of this recall.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm530199.htm