The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0017-2018·Announced 2017-11-01

Fentanyl Citrate Infusion Cassettes Recalled for Sterility Assurance Concerns

Banner Pharmacy Services is recalling fentanyl citrate infusion cassettes due to a lack of assurance of sterility. The affected products were distributed nationwide.

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, and the hazard involves a lack of assurance of sterility in a parenteral drug, which poses a significant risk of serious injury or death from infection.

Plain-English summary

Banner Pharmacy Services, LLC is recalling fentanyl citrate 1000 mcg (10 mcg/mL) 100 mL cassettes in 0.9% Sodium Chloride. The recall was initiated because of a lack of assurance of sterility in the manufacturing process. The affected products are prescription-only and were distributed nationwide within the United States.

The recall covers 9,030 cassettes. Specific lot numbers and expiration dates are listed in the official recall documentation, ranging from April 2017 to August 2017. The products were manufactured by Banner Health Compounding Pharmacy in Chandler, Arizona.

Healthcare providers and patients should stop using the affected cassettes and contact Banner Pharmacy Services or their local FDA office for further instructions. Consumers should verify the lot number and expiration date of their medication against the official recall list to determine if their product is affected.

The recalled product

Product
fentaNYL citrate 1000 mcg (10 mcg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025011001
Manufacturer
Banner Pharmacy Services, LLC
Category
Drug — Infusion Solution
Hazard
Affected units
9,030

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 #: 041317S1
  • Exp 10/10/2017
  • 041817S1
  • Exp 10/15/2017
  • 042017S1
  • 10/17/2017
  • 042517S1
  • 10/22/2017
  • 042717S1
  • Exp 10/24/2017
  • 050217S1
  • Exp 10/29/2017
  • 050417S2
  • Exp 10/31/2017
  • 050917S1
  • 11/5/2017
  • 051117S1
  • 051117S4
  • 11/7/2017
  • 051617S1

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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