FDAFDA · Food and drugs·Recall number D-1218-2014
Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Published April 16, 2014 · Recall initiated: December 12, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Zions RX Formulations Services LLC dba RX Formuations Serv.
- Distributor
- AZ
- Lot
- Lot #: 117456@3 Expiration Date: 12/12/2013 Lot #: 117907@3 Expiration Date: 12/19/2013 Lot #: 118297@8 Expiration Date: 12/25/2013
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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