The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1218-2014·Announced 2014-04-16

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Manufacturer
Zions RX Formulations Services LLC dba RX Formuations Serv.
Category
Drug — Injectable Anesthetic
Hazard
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.

See all 7 products in this recall →

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