Tri-Coast Pharmacy Inc. Voluntarily Recalling All Sterile Products Prepared Between May 17, 2016 and November 17, 2016

PUBLISHED: Nov 22, 2016
Source: Food and Drug Administration

Tri-Coast Pharmacy Inc. is voluntarily recalling all sterile products prepared between May 17, 2016 and November 17, 2016 and that remain within expiry (follow link for full list) due to Food and Drug Administration’s (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. To date, Tri-Coast Pharmacy has received no adverse event reports for these products.

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., our logo, the drug name, lot number and the expiration date. In the event a patient is unsure if their product is on the list of recalled drugs, we ask that they call the pharmacy to inquire. The phone number is 1 (561) 776-7510 or toll free at 1 (877) 823-3284.

Tri-Coast Pharmacy’s primary concern is to ensure patient safety. 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
  • Contact Tri-Coast Pharmacy Inc at 1 (561) 776-7510 or our toll free number 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 his recall.

Follow the link below for additional information about this recall.

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