FDA Recalls Fentanyl Injectable Syringes Over Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 598 fentanyl syringes due to lack of assurance of sterility. The affected lots were distributed nationwide.
What this means for you
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 Class II FDA recall of an injectable medication. The lack of assurance of sterility in fentanyl syringes represents a significant contamination risk for an injectable product. This meets the criteria for High severity as a risk-of-harm product with no reported injuries.
Plain-English summary
Central Admixture Pharmacy Services Inc. is recalling 598 units of fentanyl in 0.9% sodium chloride (100 mcg/10 mL) supplied in 10 mL syringes. The NDC number is 71286-2071-2. The affected lots are Lot 17-275476 (expiration October 4, 2023) and Lot 17-275875 (expiration October 11, 2023).
The FDA has classified this recall as Class II due to lack of assurance of sterility in the product.
The recalled product was distributed nationwide in the United States.
The recalled product
- Product
- fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2071-2
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable
- Hazard
- contamination-risk
- lack-of-sterility
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 (4)
- Lot: 17-275476
- Exp. 10/4/2023
- 17-275875
- Exp. 10/11/2023
Distribution
Distributed nationwide across the United States.
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