Recalls / Class II
Class IID-1215-2014
Product
Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
- Affected lot / code info
- Lot #: 117467@9 Expiration Date: 12/12/2013 Lot #: 117857@2 Expiration Date: 12/15/2013 Lot #: 117740@4 Expiration Date: 12/13/2013
Why it was recalled
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
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
- 95 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-1215-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.