Zions RX Formulations Recalls Bupivacaine Due to Sterility Concerns
Zions RX Formulations is recalling 60 units of Bupivacaine 3% in Arizona due to poor aseptic practices that compromised sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in injectable products, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
Zions RX Formulations Services LLC dba RX Formuations Serv. is recalling 60 units of Bupivacaine 3%, 300 mL units. The product is labeled "Not for Dispensing, For Hospital Administration Only" and was distributed in Arizona. The recall involves specific lots with expiration dates in December 2013.
The recall was initiated due to a lack of assurance of sterility resulting from poor aseptic practices observed at the firm. The company expanded the recall to other injectable products for the same reason. This is an FDA Class II recall.
Healthcare facilities and hospitals that have received these specific units should stop using them and contact the recalling firm for instructions on return or disposal. Consumers should not use this product, as it is intended for hospital administration only.
The recalled product
- Product
- Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
- Category
- Drug — Injectable Anesthetic
- Affected units
- 60
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 7 recalled by Zions RX Formulations Services LLC dba RX Formuations Serv. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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