Fentanyl Injectable Syringes Recalled Due to Sterility Assurance Issue
Central Admixture Pharmacy Services is recalling fentanyl 100 mcg/2 mL syringes due to a lack of assurance of sterility. The affected lot was 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: This is an FDA Class II recall for a sterility assurance issue. No illnesses or injuries have been reported in the source, making the hazard theoretical rather than confirmed. Per the rubric, a contamination issue without reported illness is scored at most 3, qualifying as High severity.
Plain-English summary
Central Admixture Pharmacy Services Inc is recalling fentanyl, 100 mcg/2 mL (50 mcg/mL), 3 mL syringes because of a lack of assurance of sterility. The recalled product was repackaged by CAPS Inc. at 7935 Dunbrook Road, Suite C, San Diego, CA 92126, and distributed nationwide.
The affected lot is Lot 17-275284 with an expiration date of 10/3/2023. The product carries NDC 71286-2003-1.
Healthcare providers and patients who have received this product should consult with their pharmacist or healthcare provider regarding use of affected units. Individuals should not use syringes from the recalled lot and should contact their healthcare provider or pharmacy for guidance on replacement or alternative treatment options.
Anyone with questions about this recall should contact Central Admixture Pharmacy Services Inc.
The recalled product
- Product
- fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-1
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable
- 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 (2)
- Lot: 17-275284
- Exp. 10/3/2023.
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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