Agency classClass IIOur severity:High FDA (Drugs)·D-1054-2023·Announced 2023-08-09

Fentanyl Injectable Syringes Recalled for Lack of Sterility Assurance

Central Admixture Pharmacy Services is recalling approximately 2,082 fentanyl injectable syringes distributed nationwide due to lack of validation data for sanitization cycles, which cannot assure product sterility.

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 driven by lack of sterilization assurance for an injectable pharmaceutical. The missing validation data for sanitization cycles represents a risk-of-harm situation, as inadequate sterilization of an injected medication could lead to serious infection or contamination.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling approximately 2,082 syringes of fentanyl in 0.9% sodium chloride (10 mcg/mL, 50 mL syringe). The product was distributed nationwide and is identified by NDC 71286-2071-3.

The recall was initiated due to lack of assurance of product sterility. The manufacturer lacks validation data for the sanitization cycles used to prepare the syringes. Without validated sanitization procedures, there is no documented evidence that the product meets sterility requirements.

Affected lot numbers include 17-271133, 17-271155, 17-271568, 17-271569, 17-271741, 17-271762, 17-272051, 17-272227, 17-272343, 17-272799, and 17-273495, with expiration dates from July 25, 2023 through September 4, 2023.

The recalled product

Product: fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-3
Manufacturer: Central Admixture Pharmacy Services Inc
Category: Drug
Hazard: sterility-assurance
contamination-risk
Affected units: 2,082

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: 17-271133
17-271155
Exp. 7/25/2023
17-271568
17-271569
Exp. 8/1/2023
17-271741
17-271762
Exp. 8/3/2023
17-272051
Exp. 8/9/2023
17-272227
Exp. 8/13/2023
17-272343
Exp. 8/15/2023
17-272799
Exp. 8/22/2023
17-273173
Exp. 8/29/2023
17-273495

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 39 recalled by Central Admixture Pharmacy Services Inc 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 39 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services Inc

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Ephedrine Injectable Recalled for Lack of Sterility Assurance
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Fentanyl injectable syringes recalled nationwide for sterility assurance failure
FDA (Drugs) · 2023-10-11

Same hazard · sterility assurance