EPINEPHrine Injection Recall Due to Lack of Sterility Assurance
SterRx is recalling EPINEPHrine 2 mg per 250 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects 2,779 bags distributed across the U.S.
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 product. Lack of sterility assurance in injectable medications presents a risk of serious infection and poses potential for hospitalization; injectable products contaminated with pathogens carry inherent risk of severe harm even without reported illnesses to date.
Plain-English summary
SterRx, LLC is recalling EPINEPHrine 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection, NDC 70324-027-01, due to lack of assurance of sterility. The affected product is a prescription-only injectable medication.
The recall involves 2,779 bags distributed nationwide in the U.S. The affected product code is S21257/BXC. SterRx is located at 141 Idaho Ave., Plattsburgh, NY, 12903.
Healthcare providers and patients who have received or used this product should contact their healthcare provider or pharmacist for guidance. Any unused product should be quarantined pending further instructions from the FDA or SterRx.
The recalled product
- Product
- EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-027-01.
- Manufacturer
- SterRx, LLC
- Category
- Drug — Injectable / Epinephrine
- Hazard
- sterility-failure
- infection-risk
- injectable-contamination
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)
- S21257/BXC
Distribution
Distributed nationwide across the United States.
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