The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0708-2022·Announced 2022-03-30

Norepinephrine Bitartrate Injection Recalled for Defective Container

Athenex Pharma Solutions is recalling Norepinephrine Bitartrate Injection 8 mg per 250 mL due to a defective container. The recall affects approximately 9,800 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 2/5 (Moderate).

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 a Class II recall with no reported illnesses or injuries. The hazard—a defective container—is a manufacturing/packaging issue without evidence of actual harm. Class II recalls with no hospitalization reports and no injury reports fall into the Moderate category.

Plain-English summary

Athenex Pharma Solutions, LLC is recalling Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride (NDC 76154-475-15) in 250 mL excel bags due to a defective container. Approximately 9,800 bags have been distributed nationwide.

Specific lot numbers affected are: F2101639, F2101642, F2101644, F2101645 (expiration 4/30/22); F2101674, F2101675, F2101676 (expiration 5/05/22); F2101790, F2101791, F2101792, F2101793, F2101794 (expiration 5/26/22); and F2101813 (expiration 5/29/22).

This is a voluntary, Class II recall initiated by the firm on March 14, 2022. Healthcare providers and patients should not use affected lots and should return them to Athenex Pharma Solutions, LLC for replacement or credit. Anyone with questions should contact the manufacturer at Athenex Pharma Solutions, LLC in Clarence, NY.

The recalled product

Product
Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-475-15
Manufacturer
Athenex Pharma Solutions, LLC
Category
Drug — Injectable / Cardiovascular Agent
Hazard
Affected units
9,800

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 (17)

  • Lot #: F2101639
  • F2101642
  • F2101644
  • F2101645
  • Exp 4/30/22
  • F2101674
  • F2101675
  • F2101676
  • Exp 5/05/22
  • F2101790
  • F2101791
  • F2101792
  • F2101793
  • F2101794
  • Exp 5/26/22
  • F2101813
  • Exp 5/29/22

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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