The Recall Desk
SevereFDA (Drugs)·D-0018-2018·Announced 2017-11-01

Banner Pharmacy Recalls Fentanyl Citrate Syringes Due to Sterility Concerns

Banner Pharmacy Services is recalling fentanyl citrate syringes because the agency could not ensure the product was sterile.

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 the hazard involves a lack of assurance of sterility for an injectable medication, which poses a significant risk of infection or serious injury.

Plain-English summary

Banner Pharmacy Services, LLC is recalling specific lots of fentanyl citrate 1100 mcg (20 mcg/mL) 55 mL syringes in 0.9% Sodium Chloride. The recall was initiated due to a lack of assurance of sterility for the affected products.

The affected products are prescription-only and were distributed nationwide within the United States. The recall covers seven specific lots with expiration dates ranging from January 2017 to February 2018. The NDC for the product is 7025011001.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be removed from use and returned to the pharmacy or manufacturer according to their instructions.

The recalled product

Product
fentanyl citrate (PF) 1100 mcg (20 mcg/mL) 55 mL syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025011001
Manufacturer
Banner Pharmacy Services, LLC
Category
Drug — Injectable
Hazard

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 (14)

  • Lot # :051717S1
  • Exp 11/13/2017
  • 052417S1
  • Exp 11/20/2017
  • 062117S1
  • Exp 12/18/2017
  • 071217S1
  • Exp. 1/8/2017
  • 071917S1
  • Exp 1/15/2018
  • 072617S1
  • Exp 1/22/2018
  • 081017S1
  • Exp 2/6/2018

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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