Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Reported: April 16, 2014 Initiated: December 12, 2013 #D-1218-2014
Product Description
Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Reason for Recall
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.
Details
- Recalling Firm
- Zions RX Formulations Services LLC dba RX Formuations Serv.
- Units Affected
- 60 units
- Distribution
- AZ
- Location
- Mesa, AZ
Frequently Asked Questions
What product was recalled? ▼
Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205. Recalled by Zions RX Formulations Services LLC dba RX Formuations Serv.. Units affected: 60 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 16, 2014. Severity: Moderate. Recall number: D-1218-2014.
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