D-1456-2014 Class II Ongoing

Recalled by Franck's Lab Inc dba Trinity Care Solutions — Ocala, FL

Recall Details

Product Type
Drugs
Report Date
July 30, 2014
Initiation Date
May 15, 2014
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 units

Product Description

Desferal 2.5 gm/14 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28314, Discard After 05/22/14

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.

Distribution Pattern

Florida

Code Information

Rx 28314 Exp 5/22/2014