Agency classClass IIOur severity:High FDA (Drugs)·D-1047-2023·Announced 2023-08-09

Fentanyl Injectable Syringes Recalled Due to Sterility Assurance Failure

Central Admixture Pharmacy Services is recalling 1,216 fentanyl 2500 mcg/50 mL syringes distributed nationwide due to lack of validation data for sanitization cycles, which cannot assure 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: FDA Class II recall with no reported illnesses or injuries. The hazard involves potential contamination due to lack of sterility assurance for an injectable product, which represents a risk-of-harm product where injury has not yet been reported. Per the rubric, when no illnesses are reported and the hazard is theoretical, the maximum score is 3.

Plain-English summary

Central Admixture Pharmacy Services Inc. is recalling fentanyl 2500 mcg/50 mL (50 mcg/mL) syringes distributed nationwide. The affected product is supplied in 50 mL syringes with NDC 71286-2003-3, and 1,216 syringes are included in the recall.

The recall was initiated because the manufacturer lacked adequate validation data for sanitization cycles. Without proper validation, the sterility of the injectable product cannot be assured, which is critical for medications administered intravenously or intramuscularly.

Multiple lot numbers are affected by this recall, with expiration dates ranging from July 2023 through September 2023. Healthcare professionals should refer to the FDA recall notice for specific lot numbers and expiration dates.

The recalled product

Product: fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3
Manufacturer: Central Admixture Pharmacy Services Inc
Category: Drug — Injectable Fentanyl
Hazard: lack-of-sterility
contamination-risk
Affected units: 1,216

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 (16)

Lot: 17-270771
Exp. 7/19/2023
17-271134
Exp. 7/25/2023
17-271577
Exp. 8/1/2023
17-271745
Exp. 8/3/2023
17-272026
Exp. 8/9/2023
17-272345
Exp. 8/15/2023
17-272615
Exp. 8/20/2023
17-273668
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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Fentanyl injectable syringes recalled nationwide for sterility assurance failure
FDA (Drugs) · 2023-10-11

Same hazard · lack of sterility