Fentanyl Injection Bags Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 403 bags of fentanyl injection due to lack of sterility assurance. 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 an FDA Class II recall for lack of sterility assurance. Since no illnesses or injuries are reported in the source text and the hazard is theoretical rather than confirmed contamination, the score is 3 per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 403 bags of fentanyl in 0.9% sodium chloride injection (5,000 mcg/250 mL, 20 mcg/mL) distributed nationwide. The recall affects four lots: 17-275517 (expiration 10/5/2023), 17-275862 (expiration 10/11/2023), 17-275980 (expiration 10/15/2023), and 17-276036 (expiration 10/16/2023).
The product is being recalled because of a lack of assurance of sterility. This is a Class II recall from the U.S. Food and Drug Administration.
If you have received any of the affected lots, do not use them. Contact your healthcare provider or pharmacist for instructions on how to return or dispose of the product.
The recalled product
- Product
- fentaNYL in 0.9% sodium chloride, 5,000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2074-1
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug
- Hazard
- 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 (8)
- Lot: 17-275517
- Exp. 10/5/2023
- 17-275862
- Exp. 10/11/2023
- 17-275980
- Exp. 10/15/2023
- 17-276036
- Exp. 10/16/2023.
Distribution
Distributed nationwide across the United States.
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