Recalls / Class I
Class ID-1213-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ, 85205.
- Affected lot / code info
- Lot #: 117433@15 Expiration Date: 12/07/2013 Lot #: 117446@8 Expiration Date: 12/12/2013 Lot#: 117923@8 Expiration Date: 12/19/2013
Why it was recalled
Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination found in Calcium Gluconate saturated solution that was observed upon drawing the vial contents into a syringe.
Recalling firm
- Firm
- Zions RX Formulations Services LLC dba RX Formuations Serv.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 5949 E University Dr, N/A, Mesa, Arizona 85205-7435
Distribution
- Quantity
- 450 Vials
- Distribution pattern
- AZ
Timeline
- Recall initiated
- 2013-12-12
- FDA classified
- 2014-04-07
- Posted by FDA
- 2014-04-16
- Terminated
- 2014-05-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1213-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.