FDA Recalls Fentanyl Injectable Syringes Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling fentanyl 2500 mcg/50 mL injections nationwide due to lack of assured sterility.
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 an injectable opioid lacking assured sterility. While no reported illnesses are mentioned in the source, sterility failure in injectable medications constitutes a high-risk-of-harm product that could cause serious infection.
Plain-English summary
Central Admixture Pharmacy Services Inc is recalling fentanyl 2500 mcg/50 mL (50 mcg/mL) syringes distributed nationwide. The recall is due to a lack of assurance of sterility of the product.
Affected product includes 476 syringes with lot numbers 17-275464 (expiration 10/4/2023) and 17-275850 (expiration 10/11/2023). The product NDC is 71286-2003-3.
Fentanyl is a potent opioid medication administered by injection. Failure to ensure sterility in injectable medications poses a serious risk of infection to patients. Consumers and healthcare providers who have received or dispensed this product should contact the recalling firm or their healthcare provider for further guidance.
The manufacturer is located at 7935 Dunbrook Road, Suite C, San Diego, CA 92126.
The recalled product
- Product
- fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable / Opioid
- Hazard
- sterility-failure
- infection-risk
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:17-275464
- Exp. 10/4/2023
- 17-275850
- Exp. 10/11/2023.
Distribution
Distributed nationwide across the United States.
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