The Recall Desk
SevereFDA (Drugs)·D-1217-2014·Announced 2014-04-16

Zions RX Formulations Recalls Sodium Bicarbonate Injectable Units

Zions RX Formulations is recalling 610 units of Sodium Bicarbonate 8.4% injectable products 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 serious injury or death from infection.

Plain-English summary

Zions RX Formulations Services LLC is recalling 610 units of Sodium Bicarbonate 8.4% injectable products in 10 mL, 20 mL, and 22 mL sizes. The products are labeled "Not for Dispensing, For Hospital Administration Only" and were distributed in Arizona.

The recall was initiated because of 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.

No specific illnesses or injuries are reported in the source text. Affected lots include specific expiration dates ranging from December 12, 2013, to December 25, 2013.

The recalled product

Product
Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 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
Hazard
Affected units
610

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 (8)

  • a) Lot #: 117460@5 Expiration Date: 12/12/2013
  • Lot #: 117911@5 Expiration Date: 12/19/2013
  • Lot #: 117916@6 Expiration Date: 12/19/2013
  • Lot #: 118092@63 Expiration Date: 12/18/2013
  • Lot #: 118401@31 Expiration Date: 12/25/2013
  • Lot #: 118013@24 Expiration Date: 12/18/2013
  • Lot #: 118094@64 Expiration Date: 12/18/2013
  • Lot #: 118403@32 Expiration Date: 12/25/2013

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.

See all →

Same hazard · sterility

See all →