Fentanyl and Bupivacaine Injectable Syringes Recalled for Sterility Defect
Central Admixture Pharmacy Services Inc. is recalling 895 syringes of fentanyl and bupivacaine injectable solution due to lack of assurance of sterility. The recall affects all doses 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 a risk-of-harm pharmaceutical product where no illnesses have been reported in the source text. However, a sterility defect in an injectable drug presents a serious potential hazard. The FDA Class II classification supports a High severity rating.
Plain-English summary
Central Admixture Pharmacy Services Inc. is recalling a compounded pharmaceutical product containing fentanyl 1.5 mcg/mL and bupivacaine 0.125% in 0.9% sodium chloride solution. The affected product is supplied in 50 mL syringes, with a total of 895 units recalled. The product was distributed nationwide.
The recall involves the following lot numbers: 17-275165 and 17-275166 (expiration 10/1/2023), 17-275217 (expiration 10/2/2023), 17-275715 (expiration 10/9/2023), 17-276035 (expiration 10/16/2023), and 17-276112 (expiration 10/17/2023). The reason for the recall is lack of assurance of sterility.
Healthcare providers and patients who have this medication should contact Central Admixture Pharmacy Services Inc. or consult with their healthcare provider immediately regarding this recall.
The recalled product
- Product
- fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL, 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2080-2
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable Pharmaceutical
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 (11)
- Lot: 17-275165
- 17-275166
- Exp. 10/1/2023
- 17-275217
- Exp. 10/2/2023
- 17-275715
- Exp. 10/9/2023
- 17-276035
- Exp. 10/16/2023
- 17-276112
- Exp. 10/17/2023
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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