SterRx Epinephrine Injection Recalled for Lack of Sterility Assurance
SterRx is recalling 684 bags of epinephrine in 0.9% sodium chloride injection nationwide due to lack of assurance of sterility. The product is supplied to hospitals and healthcare facilities.
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 safety hazard. Lack of sterility assurance in epinephrine injection—a life-saving emergency medication—creates significant risk of serious patient harm, including infection. While no illnesses are reported in the source text, the nature of the defect (non-sterile injectable) and the product's critical role in emergency care justify a Severe classification under the rubric.
Plain-English summary
SterRx, LLC is recalling EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), NDC 70324-627-01, lot code S21335/BZV. The recall affects 684 bags distributed nationwide in the United States.
The product is being recalled due to lack of assurance of sterility. This means the manufacturer cannot confirm that the product is free from contamination and safe for use.
Epinephrine injection is a critical emergency medication administered in hospitals and healthcare settings. Compromised sterility in injectable drugs poses a serious risk to patient safety. Consumers should not use recalled product and should contact their healthcare provider or pharmacist if they have questions about whether they have received this product.
The recalled product
- Product
- EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-627-01.
- Manufacturer
- SterRx, LLC
- Category
- Drug — Injectable / Epinephrine
- Affected units
- 684
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)
- S21335/BZV
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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