Agency classClass IIOur severity:Severe FDA (Drugs)·D-0305-2022·Announced 2022-01-05

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Affected units: 18,948

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 26 recalled by SterRx, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 26 products in this recall →

Same manufacturer · SterRx, LLC

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