Medications & Supplements/Prescription Drugs

Athenex Injectable Medications Recalled for Defective Container Bags

Agency Publication Date: March 21, 2022

Summary

Athenex Pharma Solutions, LLC is recalling 23,840 bags of injectable medications including Norepinephrine Bitartrate, Phenylephrine HCl, and Epinephrine. The recall was initiated because the Excel bags used to hold the medication were found to be defective, which can lead to leaks or a loss of product sterility. These prescription medications were distributed to hospitals, clinics, and healthcare facilities across the United States. To date, no injuries or incidents have been reported in connection with this issue.

Risk

A defective container bag can compromise the sterile environment required for injectable medications or lead to product leakage. If a non-sterile medication is administered to a patient, it could result in serious infection or other life-threatening health complications.

What You Should Do

This recall affects Norepinephrine Bitartrate, Phenylephrine HCl, and Epinephrine injections in 0.9% Sodium Chloride, packaged in 250 mL Excel bags under the Athenex Pharma Solutions brand.
Identify if your supply is affected by checking the NDC numbers (76154-474-15, 76154-476-15, 76154-475-15, 76154-493-15, 76154-494-15, 76154-491-15, or 76154-814-15) and lot numbers on the bag label. See the Affected Products section below for the full list of affected codes.
Stop using the recalled product immediately.
Contact the manufacturer, Athenex Pharma Solutions, LLC, or your distributor directly to arrange for the return of all recalled inventory.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Norepinephrine Bitartrate Injection 4 mg per 250 mL in 0.9% Sodium Chloride

Variants: 4 mg, 250 mL Excel bag

Lot Numbers:

F2101628 (Exp 4/28/22)

F2101629 (Exp 4/28/22)

F2101630 (Exp 4/28/22)

F2101631 (Exp 4/28/22)

F2101632 (Exp 4/29/22)

F2101633 (Exp 4/29/22)

F2101795 (Exp 5/27/22)

F2101796 (Exp 5/27/22)

NDC:

76154-474-15

Recall #: D-0706-2022

Product: Norepinephrine Bitartrate Injection 16 mg per 250 mL in 0.9% Sodium Chloride

Variants: 16 mg, 250 mL Excel bag

Lot Numbers:

F2101634 (Exp 3/30/22)

F2101665 (Exp 4/02/22)

F2101666 (Exp 4/02/22)

F2101788 (Exp 4/26/22)

F2101789 (Exp 4/26/22)

F2101811 (Exp 4/29/22)

F2101812 (Exp 4/29/22)

F2101815 (Exp 4/29/22)

NDC:

76154-476-15

Recall #: D-0707-2022

Product: Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride

Variants: 8 mg, 250 mL Excel bag

Lot Numbers:

F2101639 (Exp 4/30/22)

F2101642 (Exp 4/30/22)

F2101644 (Exp 4/30/22)

F2101645 (Exp 4/30/22)

F2101674 (Exp 5/05/22)

F2101675 (Exp 5/05/22)

F2101676 (Exp 5/05/22)

F2101790 (Exp 5/26/22)

F2101791 (Exp 5/26/22)

F2101792 (Exp 5/26/22)

F2101793 (Exp 5/26/22)

F2101794 (Exp 5/26/22)

F2101813 (Exp 5/29/22)

NDC:

76154-475-15

Recall #: D-0708-2022

Product: Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride

Variants: 40 mg, 250 mL Excel bag

Lot Numbers:

F2101651 (Exp 5/30/22)

NDC:

76154-493-15

Recall #: D-0709-2022

Product: Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride

Variants: 50 mg, 250 mL Excel bag

Lot Numbers:

F2101652 (Exp 5/30/22)

F2101653 (Exp 5/30/22)

F2200111 (Exp 7/27/22)

NDC:

76154-494-15

Recall #: D-0710-2022

Product: Phenylephrine HCl Injection in 0.9% Sodium Chloride

Variants: 20 mg, 250 mL Excel bag

Lot Numbers:

F2101654 (Exp 5/30/22)

F2101834 (Exp 7/03/22)

F2200110 (Exp 7/27/22)

NDC:

76154-491-15

Recall #: D-0711-2022

Product: Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride

Variants: 8 mg, 250 mL Excel bag

Lot Numbers:

F2101780 (Exp 6/21/22)

F2101781 (Exp 6/21/22)

NDC:

76154-814-15

Recall #: D-0712-2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89779

Status: Resolved

Manufacturer: Athenex Pharma Solutions, LLC

Sold By: Hospitals; Clinics; Healthcare facilities

Manufactured In: United States

Units Affected: 6 products (4,270 bags; 5,320 bags; 9,800 bags; 670 bags; 1,800 bags; 1,980 bags)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Norepinephrine Bitartrate, Phenylephrine HCl, and Epinephrine injections in 0.9% Sodium Chloride, packaged in 250 mL Excel bags under the Athenex Pharma Solutions brand.

Identify if your supply is affected by checking the NDC numbers (76154-474-15, 76154-476-15, 76154-475-15, 76154-493-15, 76154-494-15, 76154-491-15, or 76154-814-15) and lot numbers on the bag label. See the Affected Products section below for the full list of affected codes.

Stop using the recalled product immediately.

Contact the manufacturer, Athenex Pharma Solutions, LLC, or your distributor directly to arrange for the return of all recalled inventory.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Affected Products

Product: Norepinephrine Bitartrate Injection 4 mg per 250 mL in 0.9% Sodium Chloride

Variants: 4 mg, 250 mL Excel bag

Lot Numbers:

F2101628 (Exp 4/28/22)

F2101629 (Exp 4/28/22)

F2101630 (Exp 4/28/22)

F2101631 (Exp 4/28/22)

F2101632 (Exp 4/29/22)

F2101633 (Exp 4/29/22)

F2101795 (Exp 5/27/22)

F2101796 (Exp 5/27/22)

NDC:

76154-474-15

Recall #: D-0706-2022

Product: Norepinephrine Bitartrate Injection 16 mg per 250 mL in 0.9% Sodium Chloride

Variants: 16 mg, 250 mL Excel bag

Lot Numbers:

F2101634 (Exp 3/30/22)

F2101665 (Exp 4/02/22)

F2101666 (Exp 4/02/22)

F2101788 (Exp 4/26/22)

F2101789 (Exp 4/26/22)

F2101811 (Exp 4/29/22)

F2101812 (Exp 4/29/22)

F2101815 (Exp 4/29/22)

NDC:

76154-476-15

Recall #: D-0707-2022

Product: Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride

Variants: 8 mg, 250 mL Excel bag

Lot Numbers:

F2101639 (Exp 4/30/22)

F2101642 (Exp 4/30/22)

F2101644 (Exp 4/30/22)

F2101645 (Exp 4/30/22)

F2101674 (Exp 5/05/22)

F2101675 (Exp 5/05/22)

F2101676 (Exp 5/05/22)

F2101790 (Exp 5/26/22)

F2101791 (Exp 5/26/22)

F2101792 (Exp 5/26/22)

F2101793 (Exp 5/26/22)

F2101794 (Exp 5/26/22)

F2101813 (Exp 5/29/22)

NDC:

76154-475-15

Recall #: D-0708-2022

Product: Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride

Variants: 40 mg, 250 mL Excel bag

Lot Numbers:

F2101651 (Exp 5/30/22)

NDC:

76154-493-15

Recall #: D-0709-2022

Product: Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride

Variants: 50 mg, 250 mL Excel bag

Lot Numbers:

F2101652 (Exp 5/30/22)

F2101653 (Exp 5/30/22)

F2200111 (Exp 7/27/22)

NDC:

76154-494-15

Recall #: D-0710-2022

Product: Phenylephrine HCl Injection in 0.9% Sodium Chloride

Variants: 20 mg, 250 mL Excel bag

Lot Numbers:

F2101654 (Exp 5/30/22)

F2101834 (Exp 7/03/22)

F2200110 (Exp 7/27/22)

NDC:

76154-491-15

Recall #: D-0711-2022

Product: Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride

Variants: 8 mg, 250 mL Excel bag

Lot Numbers:

F2101780 (Exp 6/21/22)

F2101781 (Exp 6/21/22)

NDC:

76154-814-15

Recall #: D-0712-2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89779

Status: Resolved

Manufacturer: Athenex Pharma Solutions, LLC

Sold By: Hospitals; Clinics; Healthcare facilities

Manufactured In: United States

Units Affected: 6 products (4,270 bags; 5,320 bags; 9,800 bags; 670 bags; 1,800 bags; 1,980 bags)

Distributed To: Nationwide