FDA recall D-1051-2014

Product

HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244

Reason for recall

Lack of Assurance of Sterility: The recall is being initiated due to a 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

2014-02-05

Termination date

2017-02-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dallas, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1051-2014