Medications & Supplements/Prescription Drugs

Fagron Compounding Services LLC dba Fagron Sterile Services: Neostigmine Methylsulfate Recalled for Labeling Error on Declared Strength

Agency Publication Date: July 2, 2018

Summary

Fagron Compounding Services (operating as Fagron Sterile Services) is recalling approximately 1,230 prefilled syringes of Neostigmine Methylsulfate injection solution. This recall was initiated because syringes containing 5 mg per 5 mL of the medication may be incorrectly labeled as 3 mg per 3 mL. This labeling error could lead healthcare providers to administer an incorrect dose of the medication to patients. Consumers and healthcare facilities should contact their pharmacist or healthcare provider for guidance regarding this recall.

Risk

The labeling error causes a mismatch between the actual concentration of the drug and the amount stated on the label. This can result in a patient receiving a higher dose of neostigmine methylsulfate than intended, which could lead to severe medication errors and serious adverse health effects.

What You Should Do

Check your medical supplies for Neostigmine Methylsulfate Injection Solution in 3 mL and 5 mL prefilled syringes.
Verify the lot numbers and Beyond Use Dates (BUD) on the syringe labels. Affected lots include: Lot C274-000004690 (BUD: 09/21/18) and Lot C274-000004678 (BUD: 09/20/18).
Confirm the NDC numbers on the packaging: NDC 71266-2003-02 (for the 5 mg per 5 mL product) and NDC 71266-2003-01 (for the 3 mg per 3 mL product).
Contact your healthcare provider or pharmacist immediately for guidance if you have these products in your possession or if they have been administered.
Return any unused prefilled syringes from the affected lots to the pharmacy or place of purchase to receive a refund.
Contact Fagron Sterile Services directly at their Wichita facility at 8710 E 34th St N, Wichita, KS 67226 for further instructions on how to handle the recalled products.
For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Return to place of purchase

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Neostigmine Methylsulfate Injection Solution (5 mg per 5 mL, 5 mL prefilled syringe)

Model:

NDC 71266-2003-02

Lot Numbers:

C274-000004690 (BUD: 09/21/18)

Date Ranges: 09/21/18

Product: Neostigmine Methylsulfate Injection Solution (3 mg per 3 mL, 3 mL prefilled syringe)

Model:

NDC 71266-2003-01

Lot Numbers:

C274-000004678 (BUD: 09/20/18)

Date Ranges: 09/20/18

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80383

Status: Resolved

Manufacturer: Fagron Compounding Services LLC dba Fagron Sterile Services

Sold By: Fagron Sterile Services; ICB Laboratories

Manufactured In: United States

Units Affected: 2 products (840 prefilled syringes; 390 prefilled syringes)

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

Check your medical supplies for Neostigmine Methylsulfate Injection Solution in 3 mL and 5 mL prefilled syringes.

Verify the lot numbers and Beyond Use Dates (BUD) on the syringe labels. Affected lots include: Lot C274-000004690 (BUD: 09/21/18) and Lot C274-000004678 (BUD: 09/20/18).

Confirm the NDC numbers on the packaging: NDC 71266-2003-02 (for the 5 mg per 5 mL product) and NDC 71266-2003-01 (for the 3 mg per 3 mL product).

Contact your healthcare provider or pharmacist immediately for guidance if you have these products in your possession or if they have been administered.

Return any unused prefilled syringes from the affected lots to the pharmacy or place of purchase to receive a refund.

Contact Fagron Sterile Services directly at their Wichita facility at 8710 E 34th St N, Wichita, KS 67226 for further instructions on how to handle the recalled products.

For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Neostigmine Methylsulfate Injection Solution (5 mg per 5 mL, 5 mL prefilled syringe)

Model:

NDC 71266-2003-02

Lot Numbers:

C274-000004690 (BUD: 09/21/18)

Date Ranges: 09/21/18

Product: Neostigmine Methylsulfate Injection Solution (3 mg per 3 mL, 3 mL prefilled syringe)

Model:

NDC 71266-2003-01

Lot Numbers:

C274-000004678 (BUD: 09/20/18)

Date Ranges: 09/20/18

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80383

Status: Resolved

Manufacturer: Fagron Compounding Services LLC dba Fagron Sterile Services

Sold By: Fagron Sterile Services; ICB Laboratories

Manufactured In: United States

Units Affected: 2 products (840 prefilled syringes; 390 prefilled syringes)

Distributed To: Nationwide