Fentanyl Injectable Solution Recalled for Sterility Assurance Defect
Central Admixture Pharmacy Services is recalling fentanyl 10 mcg/mL injectable solution due to lack of assurance of sterility. The recall affects 1,767 three-milliliter syringes distributed nationwide.
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 an injectable medication with lack of sterility assurance. No illnesses or injuries have been reported in the source text. This qualifies as a risk-of-harm product where injury has not yet been reported, meeting the High category criterion per the severity rubric.
Plain-English summary
Central Admixture Pharmacy Services Inc is recalling fentanyl 10 mcg/1 mL in 0.9% sodium chloride, supplied in 3 mL syringes (NDC: 71286-2071-1). The affected lots are 17-275621 (expiration 10/8/2023), 17-275693, and 17-275725 (both expiring 10/9/2023). Approximately 1,767 syringes are involved in this recall.
The recall is due to lack of assurance of sterility. Non-sterile injectable medications can introduce contaminants directly into the bloodstream, potentially causing serious infections.
This product was distributed nationwide to healthcare facilities and pharmacies. Healthcare providers and facilities that received affected lots should stop use immediately and contact Central Admixture Pharmacy Services Inc or the FDA for return instructions.
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: 71286-2071-1
- Manufacturer
- Central Admixture Pharmacy Services Inc
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 (5)
- Lot: 17-275621
- Exp. 10/8/2023
- 17-275693
- 17-275725
- Exp. 10/9/2023
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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