Fentanyl injectable syringes recalled nationwide for sterility assurance failure
Fentanyl 1,250 mcg/25 mL syringes from Central Admixture Pharmacy Services Inc are being recalled nationwide due to lack of assurance of sterility. The manufacturer could not confirm that affected lots meet required 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 a sterile injectable medication where the manufacturer could not assure sterility standards were met. Although no illnesses or injuries have been reported, contamination of a sterile injectable product represents a clear risk-of-harm scenario without reported injury, meeting the High severity criterion.
Plain-English summary
The FDA is recalling fentanyl 1,250 mcg/25 mL injectable syringes (50 mcg/mL concentration, 30 mL syringes) manufactured by Central Admixture Pharmacy Services Inc (NDC: 71286-2003-7). The affected product consists of 1,459 syringes distributed nationwide.
The recall was initiated due to lack of assurance of sterility. These are sterile injectable products, and the manufacturer could not confirm that the syringes meet required sterility standards. Contamination of sterile injectable fentanyl could result in serious adverse effects.
Affected lot numbers are 17-275223, 17-275275, 17-275928, 17-276088, and 17-276118, with expiration dates ranging from October 2 to October 17, 2023. Healthcare providers in possession of these products should not dispense or use them. Patients who may have received fentanyl from these lots should consult their healthcare provider.
The recalled product
- Product
- fentaNYL, 1,250 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 Medication
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 (8)
- Lot: 17-275223
- 17-275275
- Exp. 10/2/2023
- 17-275928
- Exp. 10/12/2023
- 17-276088
- 17-276118
- Exp. 10/17/2023.
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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