SterRx Epinephrine Injection Recalled for Lack of Sterility Assurance
SterRx is recalling epinephrine in 0.9% sodium chloride injection (4 mg per 250 mL) nationwide due to lack of assurance of sterility. The recall affects 26,928 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 a sterile injectable pharmaceutical product. Lack of assurance of sterility in injectable medications poses a serious risk of infection, contamination, and patient harm. Although no reported illnesses or injuries are stated in the source text, the compromised sterility of an injection product distributed nationwide warrants a Severe classification under FDA Class II criteria.
Plain-English summary
SterRx, LLC is recalling EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), NDC 70324-227-01, due to lack of assurance of sterility. The product is an injectable prescription medication used for emergency treatment of severe allergic reactions and other acute conditions requiring epinephrine.
Approximately 26,928 bags have been distributed nationwide. Affected lots include S21254/BWZ (released 22-Nov-21), S21263/BXG (released 30-Nov-21), S21333/BZT (released 11-Jan-22), and S21398/CCG (released 19-Feb-22).
Consumers and healthcare providers in possession of this product should stop using it immediately and contact SterRx, LLC at 141 Idaho Ave., Plattsburgh, NY 12903 for return instructions or additional information. Because epinephrine is a life-saving emergency medication, patients who depend on this product should consult their healthcare provider about alternative supplies.
The recalled product
- Product
- EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-227-01.
- Manufacturer
- SterRx, LLC
- Category
- Drug — Injectable / Epinephrine
- Affected units
- 26,928
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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