Agency classClass IIOur severity:Severe FDA (Drugs)·D-0309-2022·Announced 2022-01-05

Epinephrine Injection Recalled for Lack of Sterility Assurance

SterRx is recalling epinephrine in 0.9% sodium chloride injection (5 mg per 250 mL) nationwide due to lack of assurance of sterility. Affected lots are identified by codes S21255/BXA, S21264/BXH, and S21328/BZO.

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 (epinephrine) with a sterility defect. Non-sterile injectables present serious risk of infection and sepsis. Although the source text does not report specific hospitalizations or illnesses, the hazard—compromised sterility of a critical emergency medication—meets the severity threshold for Class II recalls involving risk of serious adverse health consequences.

Plain-English summary

SterRx, LLC is recalling EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per mL), NDC 70324-052-01, distributed nationwide in the United States. The recall encompasses 7548 bags affected by a lack of assurance of sterility.

The affected product was manufactured under lot codes S21255/BXA (22-Jan-22), S21264/BXH (29-Jan-22), and S21328/BZO (10-Mar-22). This is a Class II recall issued by the FDA.

Patients should consult their healthcare provider immediately if they have received this product. Hospitals and healthcare facilities should stop use of affected lots and return or destroy remaining inventory according to proper pharmaceutical disposal procedures.

The recalled product

Product: EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-052-01.
Manufacturer: SterRx, LLC
Category: Drug — Injectable / Epinephrine
Hazard: lack-of-sterility
contamination-risk
infection-risk
Affected units: 7,548

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.

See all 26 products in this recall →

Same manufacturer · SterRx, LLC

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