SterRx Phenylephrine HCl Injection Recalled for Sterility Assurance Failure
SterRx is recalling phenylephrine HCl injectable solution nationwide due to lack of assurance of sterility. The affected product is a 50 mg per 250 mL injection in 0.9% sodium chloride.
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 involving a sterile injectable pharmaceutical product where sterility cannot be assured. Although no illnesses or injuries are reported in the source text, the loss of sterility assurance in an injectable product poses a direct risk of serious harm (infection, sepsis) and meets the "risk-of-harm products" criterion in the rubric.
Plain-English summary
SterRx, LLC is recalling phenylephrine HCl, 50 mg per 250 mL (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, manufactured at 141 Idaho Ave., Plattsburgh, NY 12903 (NDC 70324-901-01). A total of 23,136 bags have been distributed nationwide across the United States.
The product is being recalled due to lack of assurance of sterility. The affected product was manufactured under multiple lot and batch codes, including but not limited to codes dated from December 2021 through June 2022.
Phenylephrine HCl is an injectable medication used in medical settings. A lack of sterility assurance in injectable products presents a significant risk to patients who receive the medication. Healthcare facilities and pharmacies that received this product should immediately cease distribution and contact SterRx, LLC for further instructions. Patients who have questions about whether they received this product should consult with their healthcare provider.
The recalled product
- Product
- PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-901-01.
- Manufacturer
- SterRx, LLC
- Hazard
- sterility-failure
- contamination-risk
Distribution
Distributed nationwide across the United States.
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