FDA Recalls Fentanyl Injections Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 1,197 syringes of fentanyl injectable solution due to lack of validation for sterilization cycles. 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: FDA Class II recall for sterility assurance failure in a compounded injectable. No reported illnesses or injuries. Per rubric, Class II recalls without reported harm and with theoretical contamination hazard score at most 3 (High).
Plain-English summary
Central Admixture Pharmacy Services Inc is recalling approximately 1,197 syringes of fentanyl in dextrose 5% solution (10 mcg/mL, 30 mL syringes). This is a prescription injectable medication distributed nationwide in the USA.
The recall was initiated because the manufacturer lacks adequate validation data for the sanitization cycles used in the compounding process, raising concerns about whether the product meets sterility standards.
The affected product includes the following lot numbers and expiration dates: 17-271144 (exp. 7/25/2023), 17-271354 (exp. 7/27/2023), 17-271681 (exp. 8/2/2023), 17-271990 (exp. 8/7/2023), and 17-272457 (exp. 8/16/2023). Healthcare providers and dispensing facilities should discontinue use of affected lots. Patients who have received this product should contact their healthcare provider for guidance.
The recalled product
- Product
- fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C San Diego, CA 92126, NDC: 71286-2001-2
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable / Compounded
- Hazard
- Affected units
- 1,197
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 (10)
- Lot: 17-271144
- Exp. 7/25/2023
- 17-271354
- Exp. 7/27/2023
- 17-271681
- Exp. 8/2/2023
- 17-271990
- Exp. 8/7/2023
- 17-272457
- Exp. 8/16/2023.
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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