FDA recall D-1066-2014

Product

The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry.

Reason for recall

Lack of Assurance of Sterility: The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-04-15

Report date

2014-02-12

Termination date

2016-12-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dallas, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1066-2014