The Recall Desk
SevereFDA (Drugs)·D-0319-2022·Announced 2022-01-05

SterRx Norepinephrine Injection Recalled for Lack of Sterility Assurance

SterRx is recalling 1,044 bags of Norepinephrine 16 mg per 250 mL in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The affected product carries NDC 70324-002-01 with lot code S21194/CDW.

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 for a sterile injectable drug. Lack of sterility assurance in intravenous medications poses a significant risk of serious patient harm through infection or sepsis, warranting a Severe classification even though no specific illnesses or hospitalizations are reported in the source text.

Plain-English summary

SterRx, LLC is recalling Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 5% Dextrose Injection, Rx only, due to lack of assurance of sterility. The recall affects 1,044 bags distributed nationwide in the U.S.A. The affected product is identified by NDC 70324-002-01 and lot code S21194/CDW.

Norepinephrine is a critical care medication used intravenously. Lack of sterility assurance in injectable medications poses a risk of infection or contamination when administered to patients.

Patients or healthcare providers in possession of the recalled product should discontinue use and contact their pharmacy or healthcare facility for guidance on replacement or appropriate disposal. Healthcare providers should also check their inventory for the affected lot.

The recalled product

Product
NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-002-01.
Manufacturer
SterRx, LLC
Category
Drug — Injectable / Critical Care
Hazard
  • sterility-failure
  • contamination-risk
  • infection-risk

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)

  • S21194/CDW

Distribution

Distributed nationwide across the United States.

Related recalls

Same category