The Recall Desk
ModerateFDA (Drugs)·D-0707-2022·Announced 2022-03-30

Norepinephrine Bitartrate Injection Recalled for Defective Container

Athenex Pharma Solutions recalls Norepinephrine Bitartrate Injection due to defective container issues. The recall affects 5,320 bags distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall for a defective container issue. The source text does not report any illnesses, injuries, or hospitalizations. According to the rubric, Class II recalls without reported harm typically receive a score of 2, as the hazard is facility-related rather than involving high-risk pathogens or critical labeling errors.

Plain-English summary

Athenex Pharma Solutions, LLC is recalling Norepinephrine Bitartrate Injection 16 mg per 250 mL added to 0.9% Sodium Chloride in 250 mL excel bags due to a defective container. The recall involves 5,320 bags that were distributed nationwide.

The affected lots are: F2101634 (expiration 3/30/22), F2101665 and F2101666 (expiration 4/02/22), F2101788 and F2101789 (expiration 4/26/22), and F2101811, F2101812, and F2101815 (expiration 4/29/22). The product has NDC number 76154-476-15.

This is a Class II recall initiated voluntarily by the firm on March 14, 2022. Healthcare providers and patients who have received this product should contact their healthcare provider or pharmacist for guidance. The recall was terminated on August 4, 2022.

The recalled product

Product
Norepinephrine Bitartrate Injection 16 mg per 250 mL added to 0.9% Sodium Chloride, 16 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-476-15
Manufacturer
Athenex Pharma Solutions, LLC
Category
Drug — Injectable / Cardiovascular
Hazard
Affected units
5,320

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 (12)

  • Lot #: F2101634
  • Exp 3/30/22
  • F2101665
  • F2101666
  • Exp 4/02/22
  • F2101788
  • F2101789
  • Exp 4/26/22
  • F2101811
  • F2101812
  • F2101815
  • Exp 4/29/22

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Athenex Pharma Solutions, 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 7 products in this recall →

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