fentaNYL 1,250 mcg Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals is recalling fentaNYL 1,250 mcg/25 mL injection syringes due to lack of sterility assurance. The nationwide recall affects 1,259 syringes; patients should contact their healthcare provider.
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 FDA Class II recall affects an injectable pharmaceutical product where sterility assurance is critical. Although no illnesses or injuries have been reported, the lack of sterility assurance represents a significant risk of serious infection. Per the rubric, this qualifies as a risk-of-harm product without reported injury.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling fentaNYL 1,250 mcg/25 mL injection supplied in 25 mL single-dose syringes. The recall affects approximately 1,259 syringes distributed nationwide. The affected lots are 1223048522 (expires 12/07/23), 1223049168 (expires 01/04/24), and 1223049552 (expires 01/19/24), identified by NDC 70004-0200-17.
The recall is due to lack of assurance of sterility. Sterility is critical for injectable medications to prevent serious infections and other complications in patients.
Patients who have received this medication should contact their healthcare provider to discuss whether they need medical evaluation or follow-up care. Healthcare facilities and distributors have been notified of the recall and should cease distribution immediately.
The recalled product
- Product
- fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pharma. SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0200-17, Bar code 70004020017
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable Opioid
- Hazard
- contamination-risk
- 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 (6)
- Lot #: 1223048522
- Exp 12/07/23
- 1223049168
- Exp 01/04/24
- 1223049552
- Exp 01/19/24
Distribution
Distributed nationwide across the United States.
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