Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8 mg, 250 mL excel bag, Rx only, Athenex Ph
Summary
The FDA issued a Class II for Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8 m by Athenex Pharma Solutions, LLC. Reason: Defective container.
Details
Source
Drug Recall
External ID
D-0708-2022
Action Date
2022-03-30
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: 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
Quantity Affected: 9,800 bags
Reason for Recall
Defective container
Distribution
USA nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-14
Company
Clarence, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 78 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Athenex Pharma Solutions, LLC has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Athenex Pharma Solutions, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Athenex Pharma Solutions, LLC have FDA actions?
Athenex Pharma Solutions, LLC has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0708-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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