Epinephrine Injection Recalled for Lack of Sterility Assurance
SterRx is recalling epinephrine injection (8 mg per 250 mL) due to lack of assurance of sterility. The recall affects 5,832 bags distributed nationwide.
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 affecting sterility—a critical quality attribute for parenteral products. Loss of sterility assurance on an emergency medication like epinephrine poses a significant risk of serious infection or treatment failure, meeting the rubric criterion for Class II recalls involving significant harm risk.
Plain-English summary
SterRx, LLC is recalling Epinephrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per mL), NDC 70324-077-01, due to a lack of assurance of sterility.
The affected product was distributed nationwide in the United States. The recall involves 5,832 bags with lot codes S21255/BXA (22-Jan-22), S21264/BXH (29-Jan-22), and S21328/BZO (10-Mar-22).
Consumers and healthcare providers who have this product should stop using it. Patients should consult their healthcare provider regarding alternative treatment options. Healthcare providers and consumers are encouraged to report any adverse events to the FDA or to SterRx.
The recalled product
- Product
- EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-077-01.
- Manufacturer
- SterRx, LLC
- Category
- Drug — Injectable / Parenteral
- Affected units
- 5,832
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)
- S21255/BXA 22-Jan-22 S21264/BXH 29-Jan-22 S21328/BZO 10-Mar-22
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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