FDA Recalls Fentanyl Injectable for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling fentanyl 50 mcg/mL injectable nationwide due to lack of assurance of sterility. The product was distributed in 100 mL bags (lot 17-275322, expires 10/3/2023).
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: Although classified as FDA Class II, this recall involves an injectable medication where sterility assurance has failed. This qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity score.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling fentanyl 5,000 mcg/100 mL (50 mcg/mL) injectable solution in 100 mL bags. The affected lot number is 17-275322, with an expiration date of October 3, 2023. A total of 71 bags were distributed nationwide throughout the United States.
The reason for the recall is the manufacturer's inability to assure sterility of the product. Sterility is a critical requirement for injectable medications.
This is classified as an FDA Class II recall. For more information about this recall, consumers or healthcare providers can contact the FDA or the manufacturer.
The recalled product
- Product
- fentaNYL, 5,000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-5
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable / Parenteral
- Hazard
- sterility-assurance
- 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 (2)
- Lot:17-275322
- Exp. 10/3/2023.
Distribution
Distributed nationwide across the United States.
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