The Recall Desk
SevereFDA (Drugs)·D-0015-2018·Announced 2017-11-01

Banner Pharmacy Recalls Diltiazem HCL Bags Due to Sterility Concerns

Banner Pharmacy Services is recalling 1,359 bags of Diltiazem HCL 125 mg in 0.9% Sodium Chloride due to 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe) because it may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Banner Pharmacy Services, LLC is recalling 1,359 bags of Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag, 125 mL bag. The product is prescription-only and was distributed nationwide within the US. The recall is being conducted due to a lack of assurance of sterility.

The affected product is identified by NDC 7025018601. Specific lot numbers and expiration dates include 071817S1 (Exp 10/18/2017), 072417S1 (Exp 10/24/2017), 072517S1 (Exp 10/25/2017), 081117S1 (Exp 11/11/2017), 081517S1 (Exp 11/15/2017), and 082217S1 (Exp 11/22/2017).

Patients who have received this medication should contact their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag, 125 mL bag, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025018601
Manufacturer
Banner Pharmacy Services, LLC
Category
Drug — IV Infusion
Hazard
Affected units
1,359

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 (12)

  • Lot #: 071817S1
  • Exp 10/18/2017
  • 072417S1
  • Exp 10/24/2017
  • 072517S1
  • Exp 10/25/2017
  • 081117S1
  • Exp 11/11/2017
  • 081517S1
  • Exp 11/15/2017
  • 082217S1
  • Exp 11/22/2017

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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