Fentanyl Injection Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services Inc. is recalling 688 units of fentanyl injection nationwide because it cannot assure the product meets sterility standards.
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 an injectable medication with a sterility assurance issue. The hazard poses a risk of infection, but no hospitalizations or illnesses have been reported. The score reflects that this is a risk-of-harm product in the absence of documented injuries.
Plain-English summary
Central Admixture Pharmacy Services Inc. is recalling 688 50-milliliter syringes of fentanyl injection (10 mcg/mL). The product was distributed nationwide in the United States. The recall was initiated because the manufacturer cannot assure that the product meets sterility standards.
The affected product is identified by lot numbers 17-275341 (expires October 3, 2023) and 17-275853 (expires October 11, 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 — Injectable Opioid
- Hazard
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 (4)
- Lot: 17-275341
- Exp. 10/3/2023
- 17-275853
- Exp. 10/11/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 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.
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