Fentanyl and Bupivacaine Injectable Bags Recalled for Sterility Assurance Issues
Central Admixture Pharmacy Services Inc. is recalling fentanyl-bupivacaine injectable solution due to lack of sterility assurance. The recall affects 190 units (250 mL bags) 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 lack of sterility assurance in pharmaceutical injectable medication. While no illnesses or injuries have been reported, injectable drugs are inherently high-risk products where sterility failure could cause serious infection.
Plain-English summary
Central Admixture Pharmacy Services Inc. is recalling fentanyl 2 mcg/mL and bupivacaine 0.125% injectable solution in 0.9% sodium chloride (250 mL bags) due to lack of assurance of sterility. The manufacturer issued this Class II recall in response to potential sterility concerns.
A total of 190 units across four lot numbers have been identified: Lots 17-275974 and 17-275979 (expiration 10/15/2023), lot 17-276110 (expiration 10/17/2023), and lot 17-276234 (expiration 10/19/2023). The recalled product was distributed nationwide in the United States.
Healthcare facilities and providers who received these lots should immediately discontinue use and return the product to the manufacturer. Patients who have received injections from these batches should consult with their healthcare provider.
No illnesses or injuries have been reported to date.
The recalled product
- Product
- fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-2
- Manufacturer
- Central Admixture Pharmacy Services Inc
- 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 (7)
- Lot: 17-275974
- 17-275979
- Exp. 10/15/2023
- 17-276110
- Exp. 10/17/2023
- 17-276234
- Exp. 10/19/2023.
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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