FDA Recalls Fentanyl Syringes for Sterility Assurance Failure
Central Admixture Pharmacy Services Inc. has recalled 100 fentanyl syringes (Lot 17-273267) because validation data for sanitization cycles is lacking, preventing assurance of sterility. The product 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 involving lack of sterility assurance due to missing validation data for sanitization cycles. Although no illnesses or injuries have been reported, the hazard presents a risk of serious harm, consistent with the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services Inc. has recalled 100 syringes of fentanyl 250 mcg/5 mL (NDC: 71286-2003-2, Lot 17-273267, expiration August 31, 2023).
The reason for the recall is lack of assurance of sterility, specifically due to lack of validation data for sanitization cycles. Validation data for sanitization cycles is required to demonstrate that injectable products are maintained to required sterility standards.
The product was distributed nationwide in the United States.
The recalled product
- Product
- fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug
- Affected units
- 100
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: 17-273267
- Exp. 8/31/2023.
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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