Fentanyl in Dextrose Syringes Recalled for Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling 962 fentanyl in dextrose syringes distributed nationwide due to lack of assured sterility in the injectable pharmaceutical products.
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 an injectable opioid pharmaceutical product with lack of sterility assurance. This creates potential risk of harm through contamination and infection. The source does not report confirmed illnesses or injuries. Per the rubric, risk-of-harm products without reported injuries receive a score of 3.
Plain-English summary
Central Admixture Pharmacy Services Inc. is recalling fentanyl in dextrose 5% solution 30 mL syringes due to lack of assured sterility. The FDA issued this class II recall for 962 syringes distributed nationwide.
The affected product is fentanyl in dextrose 5%, 300 mcg per 30 mL syringe (10 mcg/mL concentration), National Drug Code 71286-2001-2. The manufacturer is Central Admixture Pharmacy Services, Inc., of San Diego, California.
The recalled lots are Lot 17-275321 (expiring 10/3/2023), Lot 17-275779 (expiring 10/10/2023), and Lot 17-275790 (expiring 10/10/2023). All syringes were distributed nationwide across the United States.
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 Opioid
- 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 (5)
- Lot:17-275321
- Exp. 10/3/2023
- 17-275779
- 17-275790
- Exp. 10/10/2023.
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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