Fentanyl-bupivacaine injection syringes recalled due to sterility assurance issue
Central Admixture Pharmacy Services is recalling 1,486 syringes of fentanyl-bupivacaine injection nationwide due to lack of validated sanitization processes that may affect product sterility.
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 lack of documented sterility assurance. While no illnesses or injuries are reported, this is a risk-of-harm product where the potential for serious infection from non-sterile injectables is inherent, meeting the criterion for Score 3.
Plain-English summary
Central Admixture Pharmacy Services Inc is recalling 1,486 syringes of fentanyl 1.5 mcg/mL and bupivacaine 0.125% in 0.9% sodium chloride (50 mL syringes) distributed nationwide in the USA. The affected product is an injectable compounded medication with NDC 71286-2080-2.
The recall was initiated due to lack of assurance of sterility resulting from lack of validation data for sanitization cycles used in the compounding process. This means the manufacturer cannot document that its sanitization procedures are adequate to ensure the sterility of the finished product. Non-sterile injectable products could pose serious health risks to patients.
The affected lot numbers are 17-270811 (exp. 7/19/2023), 17-270954 and 17-270983 (exp. 7/23/2023), 17-271231 (exp. 7/26/2023), 17-271690 (exp. 8/2/2023), 17-272204 (exp. 8/13/2023), 17-272684 (exp. 8/20/2023), 17-272992 (exp. 8/24/2023), 17-273053 (exp. 8/28/2023), and 17-273436 (exp. 9/3/2023). Healthcare providers and pharmacies who have received this product should stop using it and contact Central Admixture Pharmacy Services for instructions on return or destruction.
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 — Compounded Injectable
- Affected units
- 1,486
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 (19)
- Lot: 17-270811
- Exp. 7/19/2023
- 17-270954
- 17-270983
- Exp. 7/23/2023
- 17-271231
- Exp. 7/26/2023
- 17-271690
- Exp. 8/2/2023
- 17-272204
- Exp. 8/13/2023
- 17-272684
- Exp. 8/20/2023
- 17-272992
- Exp. 8/24/2023
- 17-273053
- Exp. 8/28/2023
- 17-273436
- Exp. 9/3/2023.
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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