The Recall Desk
SevereFDA (Drugs)·D-1216-2014·Announced 2014-04-16

Zions RX Formulations Recalls Oxytocin Bags Due to Sterility Concerns

Zions RX Formulations is recalling 1,495 bags of Oxytocin 30 Units in 500mL Sodium Chloride 0.9% due to a lack of assurance of sterility.

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 infection or serious injury.

Plain-English summary

Zions RX Formulations Services LLC is recalling 1,495 bags of Oxytocin 30 Units in 500mL Sodium Chloride 0.9% (Not for Dispensing, For Hospital Administration Only). The recall was initiated because the firm expanded its recall to other injectable products due to a lack of assurance of sterility resulting from poor aseptic practices observed at the facility.

The affected product is distributed in Arizona. Specific lot numbers and expiration dates are listed in the recall documentation, including lots expiring between December 2013 and January 2014. The product is intended for hospital administration only.

Healthcare facilities and consumers should stop using the affected product and contact the recalling firm for further instructions or a refund. This recall is classified as FDA Class II.

The recalled product

Product
Oxytocin 30 Units in 500mL Sodium Chloride 0.9% Bags, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Affected units
1,495

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 →