The Recall Desk
HighFDA (Drugs)·D-0322-2022·Announced 2022-01-05

Norepinephrine Injection Recalled Due to Lack of Sterility Assurance

SterRx is recalling 36,576 bags of Norepinephrine 16 mg per 250 mL injection (0.9% Sodium Chloride) distributed nationwide because the manufacturer cannot assure the product meets sterility requirements.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA classified this as Class II recall. The hazard is lack of sterility assurance in an injectable drug, which poses a risk of serious harm including infection if non-sterile product were administered. The source text contains no reports of actual illness or injury, making this a High (score 3) rather than Severe.

Plain-English summary

SterRx, LLC is recalling Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride Injection, distributed nationwide. The recall affects 36,576 bags with lot codes and dates ranging from November 2021 through May 2022.

The recall was issued because the manufacturer cannot assure that all units meet established sterility standards. Norepinephrine is a critical injectable medication used to treat patients with severe hypotension and shock.

Consumers and healthcare providers who have received affected lots should stop use and contact their supplier or SterRx directly. The affected product is identified by NDC 70324-926-01 and specific lot codes listed in the recall notice.

The recalled product

Product
NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Injection, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-926-01.
Manufacturer
SterRx, LLC
Category
Drug — Injectable / Critical Care
Hazard
  • lack-of-sterility
  • injectable-contamination-risk

Distribution

Distributed nationwide across the United States.

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