Recalls / Class II
Class IID-1219-2014
Product
Vitamin B-12 injections, a) 1 mL and b) 30 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
- Affected lot / code info
- a) Lot#118954@2 Exp. Date: 03/09/2014, Lot# 118917@2 Exp. Date: 03/06/2014; b) Lot #: 119379@24 Exp. Date: 01/19/2014, Lot#: 118815@27 Exp. Date: 03/03/2014
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
- 38 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-1219-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.