Ambisome 285 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28300, Discard After 02/7/14

Recall Number: D-1469-2014

Firm: Franck's Lab Inc dba Trinity Care Solutions

Classification: Class II

Status: Ongoing

Report Date: 20140730

Initiation Date: 20140515

Termination Date:

Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Ambisome 285 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28300, Discard After 02/7/14