Fentanyl Injectable Syringes Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services Inc. is recalling 1,762 fentanyl syringes nationwide due to lack of assurance of sterility. No illnesses or injuries have been reported.
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 product due to lack of sterility assurance, presenting a significant risk of contamination and infection. No illnesses or injuries have been reported, classifying it as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services Inc. is recalling fentanyl in 0.9% sodium chloride, 10 mcg/1 mL, in 3 mL syringes distributed nationwide. The recall affects 1,762 syringes with NDC 71286-2071-7.
The recall is due to a lack of assurance of sterility. Affected lot numbers are 17-275858 (expiration 10/11/2023), 17-275967, and 17-275981 (expiration 10/15/2023).
Healthcare providers and dispensing facilities should identify and quarantine affected syringes. Patients who have received these syringes should contact their healthcare provider. No illnesses or injuries have been reported as of the recall announcement.
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 71286-2071-7
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable
- Affected units
- 1,762
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: 17-275858
- Exp. 10/11/2023
- 17-275967
- 17-275981
- Exp. 10/15/2023
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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