Recalls / Class II
Class IID-1217-2014
Product
Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
- Affected lot / code info
- a) Lot #: 117460@5 Expiration Date: 12/12/2013, Lot #: 117911@5 Expiration Date: 12/19/2013, Lot #: 118301@9 Expiration Date: 12/25/2013 b) Lot #: 117462@6 Expiration Date: 12/12/2013, Lot #: 117916@6 Expiration Date: 12/19/2013, Lot #: 118305@10 Expiration Date: 12/25/2013 c) Lot #: 118011@23 Expiration Date: 12/18/2013, Lot #: 118092@63 Expiration Date: 12/18/2013, Lot #: 118401@31 Expiration Date: 12/25/2013, Lot #: 118013@24 Expiration Date: 12/18/2013, Lot #: 118094@64 Expiration Date: 12/18/2013, Lot #: 118403@32 Expiration Date: 12/25/2013
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
- 610 units
- 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-1217-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.