Fentanyl injectable product recalled for lack of sterility assurance
Central Admixture Pharmacy Services is recalling fentanyl injection product due to lack of sterility assurance. No illnesses have been reported.
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 a sterility assurance failure in an injectable drug product. Although no illnesses or injuries have been reported, lack of sterility in parenteral medications represents a significant risk-of-harm to patients who may experience infection, making this a high-severity recall.
Plain-English summary
Central Admixture Pharmacy Services Inc. is recalling fentanyl in 0.9% sodium chloride, 1,000 mcg/100 mL (10 mcg/mL), supplied in 100 mL bags (prescription only). Approximately 5,378 bags are affected by this recall.
The recall is due to a lack of assurance of sterility. This is an FDA Class II recall. Multiple lot numbers are affected, with expiration dates in October 2023.
The recalled product was distributed nationwide throughout the United States. Patients and healthcare providers in possession of affected units should discontinue use and contact their healthcare provider or the manufacturer for guidance. The specific lot numbers and expiration dates are available in the original FDA recall notice.
The recalled product
- Product
- fentaNYL in 0.9% sodium chloride, 1,000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-4
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable / Parenteral
- Hazard
- lack-of-sterility
- 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 (20)
- Lot: 17-275314
- 17-275319
- 17-275320
- 17-275324
- 17-275327
- 17-275328
- 17-275349
- Exp. 10/3/2023
- 17-275510
- 17-275531
- 17-275536
- 17-275541
- 17-275548
- Exp. 10/5/2023
- 17-275656
- Exp. 10/8/2023
- 17-275714
- Exp. 10/9/2023
- 17-275766
- 17-275786
Distribution
Distributed nationwide across the United States.
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