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
D-0230-2015
Product summary
- Event
- Event 65953
- Status
- Terminated
- Classification
- Class I
- Quantity
- Undetermined
- Official record key
drug-enforcement:D-0230-2015
Official wording
Reason: Non Sterility: Microbial contamination
Code information: Lot #: 07092013M16; Exp 09/13
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial contamination