FDA recall D-1464-2014

Product

Desferal 2 gm/8 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 27767, Discard After 05/23/14

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

Florida

Key facts

Status

Ongoing

Initiation date

2014-05-15

Report date

2014-07-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ocala, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1464-2014