The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0022-2018·Announced 2017-11-01

Banner Pharmacy Recalls Norepinephrine Bags Due to Sterility Concerns

Banner Pharmacy Services is recalling 3,550 bags of Norepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride due to a lack of assurance of sterility.

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, which corresponds to a Severe severity score under the rubric for potential serious, reversible health consequences.

Plain-English summary

Banner Pharmacy Services, LLC is recalling 3,550 bags of Norepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL. The product is a prescription-only medication manufactured by Banner Health Compounding Pharmacy in Chandler, Arizona, and was distributed nationwide within the US.

The recall was initiated due to a lack of assurance of sterility. The affected lots have expiration dates ranging from October 2017 to November 2019.

Healthcare providers and patients should stop using the affected product and contact Banner Pharmacy Services for further instructions or a replacement.

The recalled product

Product
Norepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011501
Manufacturer
Banner Pharmacy Services, LLC
Category
Drug — IV Infusion
Hazard
Affected units
3,550

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 #: 071217S2
  • Exp 10/11/2017
  • 071417S1
  • Exp 10/13/2017
  • 071917S2
  • 071917S3
  • Exp 10/18/2017
  • 072117S1
  • Exp 10/20/2017
  • 072617S2
  • 072617S3
  • Exp 10/25/2017
  • 072817S2
  • Exp 10/27/2017
  • 073117S2
  • 10/30/2017
  • 080217S2
  • Exp 11/1/2017
  • 080717S2
  • Exp 11/6/2017

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 →

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