SterRx Phenylephrine HCl Injection Recalled for Sterility Assurance
SterRx is recalling PHENYLephrine HCl 40 mg per 250 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects approximately 20,640 bags distributed across the United States.
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 an injectable drug involving a fundamental sterility defect. Injectable products without assured sterility pose serious risk of infection and hospitalization; the hazard is systemic and affects a large distributed population, meeting the criteria for Severe.
Plain-English summary
SterRx, LLC is recalling PHENYLephrine HCl, 40 mg per 250 mL (160 mcg per mL) in 0.9% Sodium Chloride Injection, NDC 70324-252-01, a prescription injectable medication. The recall was initiated due to lack of assurance of sterility.
Approximately 20,640 bags have been distributed nationwide throughout the United States. The affected product includes multiple lot codes issued between December 2021 and April 2022.
Patients and healthcare providers who have this product in stock should discontinue use and contact SterRx for return instructions. Healthcare facilities should verify that affected lots are not in active use and quarantine any remaining stock.
The recalled product
- Product
- PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-252-01.
- Manufacturer
- SterRx, LLC
- Category
- Drug — Injectable / Parenteral
- Affected units
- 20,640
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.
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