Fentanyl Injectable Solution Recalled Over Sterility Concerns
Central Admixture Pharmacy Services Inc. is recalling fentanyl injectable solution nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.
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 product is a risk-of-harm injectable medication (fentanyl). The source text does not report any illnesses, injuries, or deaths. The hazard (lack of sterility assurance) is theoretical rather than confirmed contamination. Per the rubric, a risk-of-harm product where injury has not yet been reported ranks as High severity.
Plain-English summary
Central Admixture Pharmacy Services Inc. is recalling 1,792 bags of fentanyl in 0.9% sodium chloride, 2,500 mcg/250 mL (10 mcg/mL), due to lack of assurance of sterility. This injectable solution (NDC 71286-2071-5) was distributed nationwide in the United States.
The FDA classified this as a Class II recall. Multiple lot numbers are involved, with expiration dates in October 2023.
The recalled product
- Product
- fentaNYL in 0.9% sodium chloride, 2,500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Opioid Injection
- Hazard
- Affected units
- 1,792
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 (18)
- Lot: 17-275164
- exp. 10/1/2023
- 17-275623
- 17-275631
- 17-275640
- 17-275649
- 17-275650
- 17-275655
- 17-275660
- Exp. 10/8/2023
- 17-275712
- 17-275713
- 17-275721
- 17-275723
- 17-275727
- Exp. 10/9/2023
- 17-276232
- 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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