D-1470-2014 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
1 unit

Product Description

ANA Kit, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28838, Discard After 03/4/15

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 # 28838, Exp 03/4/15