FDA Recalls Injectable Fentanyl-Bupivacaine Mixture for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling fentanyl-bupivacaine injectables due to lack of assurance of sterility. The recalled 250 mL bags were 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 of an injectable medication with unassured sterility. While no illnesses or injuries have been reported, injectable drugs lacking sterility assurance pose significant infection risk. Per the rubric, high-risk hazards without reported illness are classified as High.
Plain-English summary
Central Admixture Pharmacy Services Inc is recalling fentanyl 2 mcg/mL and bupivacaine 0.0625% in 0.9% sodium chloride solution due to lack of assurance of sterility. The product consists of 250 mL bags with lot number 17-275929 and expiration date of October 12, 2023, and was distributed nationwide in the United States.
Patients or healthcare providers who have received this product should contact their healthcare provider or the manufacturer for guidance. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2081-1
- Manufacturer
- Central Admixture Pharmacy Services Inc
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: 17-275929
- Exp. 10/12/2023
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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