Fentanyl Injectable Syringes Recalled for Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 2,340 fentanyl syringes distributed nationwide due to lack of sterility assurance from unvalidated sanitization procedures.
What this means for you
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 a high-risk injectable medication (fentanyl) where sterility assurance is compromised due to unvalidated sanitization procedures. No illnesses or injuries have been reported; the hazard is potential contamination that could cause serious infection if the product was compromised.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling fentanyl in 0.9% sodium chloride (10 mcg/1 mL) supplied in 3 mL syringes. The recall affects 2,340 units distributed nationwide in the USA.
The recall was issued because the manufacturer lacked validation data for the sanitization cycles used during manufacturing. This insufficient validation means sterility of the product cannot be assured.
The affected lot numbers are 17-270813 (expiration 7/19/2023), 17-271485 (7/31/2023), 17-271809 (8/6/2023), 17-272314 (8/14/2023), 17-272780 (8/22/2023), 17-273141 (8/29/2023), and 17-273687 (9/6/2023). The product is distributed under NDC 71286-2071-7.
Healthcare providers and patients should stop using affected syringes immediately. Units with these lot numbers should be removed from use and returned to the manufacturer if possible. Contact Central Admixture Pharmacy Services or the FDA with any questions about this recall.
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 / Fentanyl
- Affected units
- 2,340
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 (14)
- Lot: 17-270813
- Exp. 7/19/2023
- 17-271485
- Exp. 7/31/2023
- 17-271809
- Exp. 8/6/2023
- 17-272314
- Exp. 8/14/2023
- 17-272780
- Exp. 8/22/2023
- 17-273141
- Exp. 8/29/2023
- 17-273687
- Exp. 9/6/2023.
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.
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