The Recall Desk
SevereFDA (Drugs)·D-0023-2018·Announced 2017-11-01

Banner Pharmacy Recalls Oxytocin Infusion Bags Due to Sterility Concerns

Banner Pharmacy Services is recalling Oxytocin 30 units in 0.9% Sodium Chloride bags because the FDA determined there is 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, which corresponds to a Severe severity score under the rubric for drug recalls involving potential serious health consequences.

Plain-English summary

Banner Pharmacy Services, LLC is recalling Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL bags. The recall is being conducted because the FDA identified a lack of assurance of sterility for the product. The affected product is prescription-only and was distributed nationwide within the United States.

The recall covers 24,306 units of the medication. Specific lot numbers and expiration dates are listed in the official recall documentation, ranging from July 2017 to August 2017. The product was manufactured by Banner Health Compounding Pharmacy in Chandler, Arizona.

Healthcare providers and patients should stop using the affected lots and contact Banner Pharmacy Services or the FDA for further instructions. Consumers should not attempt to use the product if they are unsure whether it is part of the recall.

The recalled product

Product
OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025000101
Manufacturer
Banner Pharmacy Services, LLC
Category
Drug — Compounded Medication
Hazard
Affected units
24,306

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 (20)

  • Lot#: 072017S4
  • Exp 11/16/2017
  • 072117S2
  • Exp 11/17/2017
  • 072417S2
  • Exp 11/20/2017
  • 072717S5
  • Exp 11/23/2017
  • 072817S3
  • Exp 11/24/2017
  • 073117S3
  • Exp 11/27/2017
  • 080217S3
  • Exp 11/29/2017
  • 080317S3
  • Exp 11/30/2017
  • 080917S3
  • Exp 12/6/2017
  • 081117S4
  • Exp 12/8/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 recalled by Banner Pharmacy Services, LLC 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 14 products in this recall →

Related recalls

Same manufacturer · Banner Pharmacy Services, LLC

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Same hazard · sterility

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