Fentanyl Injection Syringes Recalled for Sterilization Validation Failure
Central Admixture Pharmacy Services recalls 150 fentanyl injection syringes nationwide because sterilization procedures were not properly validated.
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 pharmaceutical product with potential contamination risk due to lack of validated sterilization procedures. No illnesses or injuries have been reported, but the hazard involves a high-risk injectable product where contamination from inadequate sterilization could pose serious harm.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling fentanyl injection syringes (fentanyl 100 mcg/2 mL) because the company could not provide validation data for its sanitization cycles. This raises concerns about whether the sterilization process was adequate and whether the syringes met required sterility standards.
The recall affects approximately 150 syringes distributed nationwide. Three specific lot numbers are involved: Lot 17-272549 (expires 8/15/2023), Lot 17-273342 (expires 8/31/2023), and Lot 17-274076 (expires 9/13/2023).
If you have received any of these syringes, do not use them. Check the product label for the lot number and expiration date to determine if your product is included in the recall. Contact your healthcare provider or pharmacist immediately to discuss the recall and any concerns about your treatment.
The recalled product
- Product
- fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-1
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug
- Affected units
- 150
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 (6)
- Lot: 17-272549
- Exp. 8/15/2023
- 17-273342
- Exp. 8/31/2023
- 17-274076
- Exp. 9/13/2023.
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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