FDA recall D-0311-2015

Vann Healthcare Services Inc · Class II · drug

Product

Lidocaine 4% Syr (PF) Rx, 1 mL packaged in 3 mL syringes, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141

Reason for recall

Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.

Distribution

KY

Key facts

Status
Terminated
Initiation date
2014-10-14
Report date
2014-12-31
Termination date
2015-07-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Glasgow, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0311-2015