FDA recall D-1111-2014

Product

EDTA 3% ophthalmic

Reason for recall

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Distribution

NC

Key facts

Status

Terminated

Initiation date

2013-11-01

Report date

2014-03-12

Termination date

2014-04-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Asheville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1111-2014