FDA Drug Class II — Moderate

TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/1mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy

Hazard

Lack of Assurance of Sterility

Products

TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/1mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy
Brand
Tri-Coast Pharmacy
UPC
Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05232016E (07/07/2016), 06092016C (07/17/2016), 05022016E (05/22/2016), 06232016D (08/04/2016), 06202016B (07/17/2016), 06152016E (07/17/2016), 06082016E (07/17/2016), 06022016C (07/17/2016), 07282016F (09/08/2016), 07262016G (09/04/2016), 07222016D (09/04/2016), 07192016D (09/01/2016), 07152016F (08/22/2016), 07082016C (08/22/2016), 08292016C (09/29/2016), 08052016C (09/16/2016), 08042016H (09/18/2016), 08022016E (09/16/2016), 09272016C (11/06/2016), 11012016B (12/09/2016), 05192016B (07/03/2016), 06132016F (07/17/2016), 06292016D (08/04/2016), 06222016E (08/04/2016), 06162016B (07/31/2016), 06132016C (07/17/2016), 06072016D (07/17/2016), 06012016D (07/16/2016), 07222016E (09/04/2016), 07202016A (09/01/2016), 07182016C (09/01/2016), 07132016B (08/22/2016), 07062016E (08/04/2016), 08092016F (09/18/2016), 08042016J (09/06/2016), 08032016D (09/16/2016), 09072016D (09/29/2016), 10132016C (11/24/2016).

Units Affected

141 vials