Agency classClass IIOur severity:High FDA (Drugs)·D-1061-2023·Announced 2023-08-09

Fentanyl Injectable Solution Recalled for Sterility Validation Failure

Central Admixture recalls 8,146 bags of fentanyl injection due to lack of sterilization cycle validation. This Class II recall affects patients nationwide who may receive contaminated IV medication.

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 of a high-risk injectable opioid due to lack of sterilization validation. Although no illnesses or injuries have been reported, the potential for microbial contamination of a potent opioid product poses significant risk to patients receiving intravenous administration.

Plain-English summary

Central Admixture Pharmacy Services Inc. is recalling fentanyl in 0.9% sodium chloride (2500 mcg/250 mL) injectable solution. The recall affects 8,146 bags distributed nationwide, with multiple lot numbers and expiration dates ranging from July through September 2023.

The recall is due to lack of assurance of sterility resulting from lack of validation data for sanitization cycles. The manufacturer failed to adequately validate that its sterilization processes ensure the product remains sterile and safe for intravenous administration.

This prescription fentanyl injection was distributed nationwide in the United States. Fentanyl is a potent opioid used for pain management and anesthesia, typically administered intravenously in healthcare settings. The concern is that patients may have received contaminated medication if affected lots were used.

The recalled product

Product: fentaNYL in 0.9% sodium chloride, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5
Manufacturer: Central Admixture Pharmacy Services Inc
Category: Drug — Injectable Opioid
Hazard: sterility-failure
microbial-contamination
Affected units: 8,146

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: 17-270584
17-270586
17-270597
17-270613
Exp. 7/17/2023
17-270655
17-270659
17-270741
Exp. 7/18/2023
17-270872
17-270875
Exp. 7/20/2023
17-271040
17-271041
17-271042
17-271058
17-271066
17-271071
17-271080
Exp. 7/24/2023

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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Same hazard · sterility failure