Medications & Supplements/Prescription Drugs

Premier Pharmacy Labs Inc: Mitomycin Irrigation Recalled for Incorrect Label Strength

Agency Publication Date: January 12, 2018

Summary

Premier Pharmacy Labs Inc. is recalling 193 vials of Mitomycin 40 mg/mL Preservative Free Irrigation (10 mL single dose vials). This recall was initiated because of a labeling error where the declared strength of the medication on the label does not match the actual concentration. Consumers should be aware that this is a compounded medication distributed nationwide to healthcare facilities and providers.

Risk

A labeling error regarding the declared strength of a medication can lead to a patient receiving an incorrect dose of Mitomycin. This can result in either under-treatment or potential toxicity if the actual strength is higher than what is indicated on the label.

What You Should Do

Check your medication supply for Mitomycin 40 mg/mL Preservative Free Irrigation in 10 mL single dose vials with NDC 69623-160-35.
Verify if your vials belong to lot number MIT100217SVDS with a Beyond Use Date (BUD) of 03/01/2018.
If you have an affected product, stop using it immediately and secure it to ensure it is not administered to patients.
Contact your healthcare provider or pharmacist for guidance regarding this recall and to discuss alternative treatments if necessary.
Return any unused vials of the affected lot to the place of purchase for a refund and contact Premier Pharmacy Labs Inc. for further instructions.
For additional questions, 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

Healthcare provider consultation and pharmacy refund

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

Affected Products

Product: Mitomycin 40 mg/mL Preservative Free Irrigation (10 mL SDV)

Model:

NDC: 69623-160-35

Lot Numbers:

MIT100217SVDS (BUD: 03/01/2018)

Date Ranges: BUD: 03/01/2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78928

Status: Resolved

Manufacturer: Premier Pharmacy Labs Inc

Sold By: hospitals; clinics; healthcare providers

Manufactured In: United States

Units Affected: 193 vials

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 medication supply for Mitomycin 40 mg/mL Preservative Free Irrigation in 10 mL single dose vials with NDC 69623-160-35.

Verify if your vials belong to lot number MIT100217SVDS with a Beyond Use Date (BUD) of 03/01/2018.

If you have an affected product, stop using it immediately and secure it to ensure it is not administered to patients.

Contact your healthcare provider or pharmacist for guidance regarding this recall and to discuss alternative treatments if necessary.

Return any unused vials of the affected lot to the place of purchase for a refund and contact Premier Pharmacy Labs Inc. for further instructions.

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