Unasyn (ampicillin/sulbactam) 1.5 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29082, Discard After 05/19/14
Recall Number: D-1463-2014
Firm: Franck's Lab Inc dba Trinity Care Solutions
Classification: Class II
Status: Ongoing
Report Date: 20140730
Initiation Date: 20140515
Termination Date:
Reason for Recall
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.
Product Description
Unasyn (ampicillin/sulbactam) 1.5 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29082, Discard After 05/19/14