Agency classClass IIOur severity:High FDA (Drugs)·D-1062-2023·Announced 2023-08-09

Fentanyl Injectable Syringes Recalled for Sterility Assurance Concerns

Central Admixture Pharmacy Services is recalling 2,340 fentanyl syringes distributed nationwide due to lack of sterility assurance from unvalidated sanitization procedures.

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: FDA Class II recall of a high-risk injectable medication (fentanyl) where sterility assurance is compromised due to unvalidated sanitization procedures. No illnesses or injuries have been reported; the hazard is potential contamination that could cause serious infection if the product was compromised.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling fentanyl in 0.9% sodium chloride (10 mcg/1 mL) supplied in 3 mL syringes. The recall affects 2,340 units distributed nationwide in the USA.

The recall was issued because the manufacturer lacked validation data for the sanitization cycles used during manufacturing. This insufficient validation means sterility of the product cannot be assured.

The affected lot numbers are 17-270813 (expiration 7/19/2023), 17-271485 (7/31/2023), 17-271809 (8/6/2023), 17-272314 (8/14/2023), 17-272780 (8/22/2023), 17-273141 (8/29/2023), and 17-273687 (9/6/2023). The product is distributed under NDC 71286-2071-7.

Healthcare providers and patients should stop using affected syringes immediately. Units with these lot numbers should be removed from use and returned to the manufacturer if possible. Contact Central Admixture Pharmacy Services or the FDA with any questions about this recall.

The recalled product

Product: fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-7
Manufacturer: Central Admixture Pharmacy Services Inc
Category: Drug — Injectable / Fentanyl
Hazard: lack-of-sterility
contamination-risk
Affected units: 2,340

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 (14)

Lot: 17-270813
Exp. 7/19/2023
17-271485
Exp. 7/31/2023
17-271809
Exp. 8/6/2023
17-272314
Exp. 8/14/2023
17-272780
Exp. 8/22/2023
17-273141
Exp. 8/29/2023
17-273687
Exp. 9/6/2023.

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 · lack of sterility