SterRx Fentanyl Citrate Injection recalled for lack of sterility assurance
SterRx is recalling Fentanyl Citrate in 0.9% Sodium Chloride Injection (2.5 mg per 250 mL) distributed nationwide due to lack of assurance of sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. Fentanyl is a potent opioid used in clinical settings where sterility is critical to prevent serious infection; failure of sterility assurance in an injectable pharmaceutical meets the criteria for Severe severity.
Plain-English summary
SterRx, LLC is recalling Fentanyl Citrate in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL (10 mcg per mL), supplied in 5,000 bags. The product is manufactured by SterRx, LLC, located at 141 Idaho Ave., Plattsburgh, NY 12903 (NDC 70324-327-02). The recall was issued due to lack of assurance of sterility.
The affected product was distributed nationwide throughout the United States. Lot codes include S21353/CAM dated 26-Mar-22, S21358/CAR dated 30-Mar-22, and S21364/CAX dated 6-Apr-22.
Patients and healthcare providers who have received or administered this product should contact their healthcare provider for guidance. The FDA classifies this as a Class II recall.
The recalled product
- Product
- Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-327-02.
- Manufacturer
- SterRx, LLC
- Category
- Drug — Injectable / Opioid
- Hazard
- sterility-assurance
- injection-safety
- 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 (1)
- S21353/CAM 26-Mar-22 S21358/CAR 30-Mar-22 S21364/CAX 6-Apr-22
Distribution
Distributed nationwide across the United States.
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