The Agency is notifying all healthcare providers of the voluntary recall launched by Tri Coast Pharmacy Inc. on all of its sterile products prepared between May 17, 2016 and November 17, 2016. The recalled products, used for a variety of indications, all carry a Tri-Coast Pharmacy Inc. label that includes the name, logo, drug name, lot number, and expiration date.

 

Reason for Recall

The recall was initiated as a result of the FDA’s concern that the conditions under which the drugs were produced introduce a lack of sterility assurance for the products.

 

Possible associated risks

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.

 

Healthcare provider’s action

All 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:

 

Discontinue the use of any products contained in the recall

Providers who have dispensed any sterile products prepared between May 17, 2016 and November 17, 2016 to a patient should make the patient(s) aware of this recall.

Healthcare providers and patients should report adverse events associated with the use of these products to the nearest NAFDAC office, NAFADC PRASCOR (20543 TOLL FREE from all networks) or via [email protected]

 

NAFDAC……..Safeguarding the Health of the Nation!!!