The Recall Desk
SevereFDA (Drugs)·D-1219-2014·Announced 2014-04-16

Zions RX Formulations Recalls Vitamin B-12 Injections Due to Sterility Concerns

Zions RX Formulations Services LLC is recalling specific lots of Vitamin B-12 injections due to a lack of assurance of sterility resulting from poor aseptic practices.

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 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 38 units of Vitamin B-12 injections, including 1 mL and 30 mL units intended for hospital administration only. The affected lots are distributed in Arizona and include specific lot numbers and expiration dates listed in the recall notice.

The recall was initiated because the firm expanded its recall to other injectable products due to a lack of assurance of sterility. This issue stems from poor aseptic practices observed at the manufacturing facility. The FDA has classified this recall as Class II.

Hospitals and healthcare facilities that have received these specific lots should stop using the product and contact the recalling firm for instructions on return or disposal. Consumers should not attempt to use these products, as they are labeled 'Not for Dispensing' and 'For Hospital Administration Only.'

The recalled product

Product
Vitamin B-12 injections, a) 1 mL and b) 30 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 Medication
Hazard
Affected units
38

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • a) Lot#118954@2 Exp. Date: 03/09/2014
  • Lot# 118917@2 Exp. Date: 03/06/2014
  • b) Lot #: 119379@24 Exp. Date: 01/19/2014
  • Lot#: 118815@27 Exp. Date: 03/03/2014

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 →

Related recalls

Same manufacturer · Zions RX Formulations Services LLC dba RX Formuations Serv.

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Same hazard · sterility

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