FDA recall D-0230-2015

Specialty Compounding, LLC · Class I · drug

Product

CALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% for Injection, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613

Reason for recall

Non Sterility: Microbial contamination

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2013-08-09
Report date
2014-11-05
Termination date
2016-09-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cedar Park, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0230-2015