Phenylephrine HCL Injection Recalled for Lack of Sterility Assurance
SterRx is recalling approximately 18,948 bags of Phenylephrine HCL in 0.9% Sodium Chloride injection nationwide due to lack of assurance of sterility. The product is distributed across the U.S.A.
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: This is an FDA Class II recall of a sterile injectable drug with a critical manufacturing defect (lack of sterility assurance). Injectable products lacking sterility assurance pose a direct risk of serious infection and contamination, meeting the threshold for Severe (4) per the rubric criterion for Class II recalls with significant risk of harm.
Plain-English summary
SterRx, LLC is recalling Phenylephrine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), an intravenous injection medication. Approximately 18,948 bags have been distributed nationwide.
The recall is being issued because there is a lack of assurance of sterility for this product. Phenylephrine HCL is a prescription medication used as a vasopressor agent, and sterility is critical for injectable pharmaceutical products to prevent serious infections and contamination.
Affected lot codes include S21086/BQW (14-Dec-21), S21149/BTH (23-Jan-22), S21159/BTQ (30-Jan-22), S21265/BXI (3-Apr-22), S21305/BYU (24-Apr-22), and S21311/BZA (26-Apr-22). The product is identified by NDC 70324-701-01.
Patients and healthcare providers who have this product should stop using it and contact their pharmacy or healthcare provider. Healthcare facilities should quarantine any remaining stock and report any adverse events to the FDA MedWatch program.
The recalled product
- Product
- PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-701-01.
- Manufacturer
- SterRx, LLC
- Category
- Drug — Injectable / Vasopressor
- Hazard
- sterility-assurance
- contamination-risk
- infection-risk
Distribution
Distributed nationwide across the United States.
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