The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0021-2018·Announced 2017-11-01

Banner Pharmacy Recalls Midazolam Cassettes Due to Sterility Concerns

Banner Pharmacy Services is recalling 966 cassettes of Midazolam HCL 100 mg 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 source text identifies the agency classification as Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are classified as Severe (Score 4). While specific injury reports are not detailed in the snippet, the 'Lack of Assurance of Sterility' for an injectable drug represents a significant risk of serious harm, aligning with the Severe criteria for Class II drug recalls.

Plain-English summary

Banner Pharmacy Services, LLC is recalling 966 cassettes of Midazolam HCL 100 mg (1mg/mL) 100 mL in 0.9% Sodium Chloride. The recall is being conducted because of a lack of assurance of sterility in the product. The affected products are prescription-only and were manufactured by Banner Health Compounding Pharmacy in Chandler, Arizona.

The recall covers specific lots with expiration dates ranging from October 23, 2017, to February 26, 2018. The affected lot numbers are 042617S4, 060817S1, 070517S2, 072817S1, 080117S2, and 083017S1. These products were distributed nationwide within the United States.

Healthcare providers and patients should stop using the affected cassettes and contact Banner Pharmacy Services for further instructions or a replacement. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Midazolam HCL 100 mg (1mg/mL) 100 mL Cassette in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 95226, NDC 7025016201
Manufacturer
Banner Pharmacy Services, LLC
Category
Drug — Injectable
Hazard
Affected units
966

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 (13)

  • Lot #: 042617S4
  • Exp 10/23/2017
  • 060817S1
  • Exp 12/5/2017
  • 070517S2
  • Exp 1/1/2018
  • 072817S1
  • Exp 1/24/2018
  • 080117S2
  • Exp 1/28/2018
  • 083017S1
  • Exp
  • 2/26/2018

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 →

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