FDA Recall D-0230-2015
Specialty Compounding, LLC · Cedar Park, TX
Class I — life-threatening Terminated 1140 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Recall record
- Recall number
D-0230-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2013-08-09
- Classified by FDA Center
- 2014-10-30
- FDA published
- 2014-11-05
- Terminated
- 2016-09-22
- Recalling firm
- Specialty Compounding, LLC
- Firm location
- Cedar Park, TX