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Class II: temporary or reversible health riskTerminated

Athenex Pharma Solutions Norepinephrine Bitartrate Injection 16 mg Recall

Norepinephrine Bitartrate Injection 16 mg per 250 mL added to 0

Athenex Pharma Solutions, LLC · Clarence, NY

Risk level
Class II
Reported by FDA
Mar 30, 2022
Recall ID
D-0707-2022
Check your lot numberHow we source this data

Summary

Athenex Pharma Solutions recalled Norepinephrine Bitartrate Injection 16 mg starting Mar 14, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0707-2022 on Mar 30, 2022. Reason: Defective container. Status: Terminated.

Why it was recalled

Defective container

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

USA nationwide.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0707-2022
Classification
Class II
Status
Terminated
Recall initiated
Mar 14, 2022
FDA report date
Mar 30, 2022
Quantity
5,320 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Athenex Pharma Solutions, LLC

Original FDA data

Every field from FDA enforcement report D-0707-2022, exactly as published.

Show all FDA fields
City
Clarence
State
NY
Status
Terminated
Country
United States
Event ID
89779
Address
11342 Main St
Code information
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
Postal code
14031-1718
Report date
Mar 30, 2022
Product type
Drugs
Recall number
D-0707-2022
Classification
Class II
Recalling firm
Athenex Pharma Solutions, LLC
Product quantity
5,320 bags
Termination date
Aug 4, 2022
Reason for recall
Defective container
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
USA nationwide.
Recall initiation date
Mar 14, 2022
Initial firm notification
Letter
Center classification date
Mar 21, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0707-2022, published Mar 30, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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