Agency classClass IIOur severity:High FDA (Drugs)·D-0355-2023·Announced 2023-03-08

Diltiazem HCl Injectable Drug Recalled for Sterility Assurance Failure

Nephron Sterile Compounding Center is recalling Diltiazem HCl injectable due to lack of sterility assurance. The FDA Class II recall affects 4,743 bottles 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for an injectable medication. No illnesses, injuries, or deaths are reported in the source. Per the severity rubric, this scores 3 (High) as a risk-of-harm product (injectable with potential for serious infections if contaminated) where injury has not yet been reported. Class II status without reported harm does not meet the threshold for Score 4 (Severe).

Plain-English summary

Nephron Sterile Compounding Center LLC is recalling Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (125 mL single-dose bottles). The affected lot is DS2053, expiration date February 27, 2023, with approximately 4,743 bottles distributed nationwide.

The FDA determined that this lot lacks assurance of sterility. Sterility is critical for injectable medications to prevent potentially serious infections.

Healthcare facilities and pharmacies that received product from lot DS2053 should identify any remaining inventory and follow appropriate quarantine procedures. Patients or individuals who received injections from this batch should consult their healthcare provider.

The recalled product

Product: Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-997-15.
Manufacturer: Nephron Sterile Compounding Center LLC
Category: Drug — Injectable / Intravenous
Hazard: sterility-failure
contamination-risk
Affected units: 4,743

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 (2)

Lots: DS2053
Exp. 2/27/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Nephron Sterile Compounding Center 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 8 products in this recall →

Same manufacturer · Nephron Sterile Compounding Center LLC

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Same hazard · sterility failure