Agency classClass IIOur severity:High FDA (Drugs)·D-1043-2023·Announced 2023-08-09

Fentanyl injection syringes recalled for unvalidated sterilization process

Central Admixture Pharmacy Services is recalling 5,124 fentanyl syringes because the manufacturer lacks validation that its sterilization process is effective. The nationwide recall affects multiple lot numbers distributed through September 2023.

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 injectable medication with unvalidated sterilization processes, presenting a potential contamination risk. No illnesses or injuries are mentioned in the source document, supporting the criterion for 'risk-of-harm products where injury has not yet been reported' (score 3).

Plain-English summary

Central Admixture Pharmacy Services Inc. is recalling 5,124 fentanyl syringes (1250 mcg/25 mL, 50 mcg/mL) distributed nationwide. The recall is due to a lack of validation data for the sanitization cycles used to sterilize the product.

Without proper validation that the sterilization process works, there is no assurance that the syringes are sterile. Lack of sterilization in injectable medications presents a potential contamination risk.

The affected syringes have lot numbers ranging from 17-270664 through 17-274208, with expiration dates from July 2023 through September 2023. The manufacturer's NDC is 71286-2003-7. Patients and healthcare providers who have these syringes should discontinue use and contact the manufacturer or the FDA with questions.

The recalled product

Product: fentaNYL, 1250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-7
Manufacturer: Central Admixture Pharmacy Services Inc
Category: Drug — Injectable / Fentanyl
Hazard: contamination
sterility
Affected units: 5,124

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: 17-270664
Exp. 7/18/2023
17-270886
Exp. 7/20/2023
17-270976
17-270989
Exp. 7/23/2023
17-271335
Exp. 7/27/2023
17-271572
Exp. 8/1/2023
17-271747
Exp. 8/3/2023
17-271808
Exp. 8/6/2023
17-272023
Exp. 8/9/2023
17-272203
Exp. 8/13/2023
17-272718

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 · contamination