Medications & Supplements/Prescription Drugs

Medical Center Pharmacy, Inc.: Various Compounded Sterile Drugs Recalled for Potential Sterility Concerns

Agency Publication Date: April 1, 2020

Summary

Medical Center Pharmacy, Inc. is recalling eight units of five different compounded sterile medications, including Albumin eye drops and Vancomycin eye drops, due to production issues that cannot guarantee the products are sterile. This recall includes specialized eye drops, a Morphine cassette, and bladder irrigation bags that were distributed to specific patients in Tennessee. Using a non-sterile product intended for the eyes or for injection can lead to serious infections and other health complications. Consumers should stop using these specific products and contact their healthcare provider or pharmacist immediately.

Risk

The medications were produced using processes that lack assurance of sterility, meaning the products could be contaminated with bacteria or other microbes. Administering a contaminated drug directly into the eye, bladder, or bloodstream can cause severe, potentially life-threatening infections.

What You Should Do

Identify if you have any of the affected medications by checking the product labels for the name 'Medical Center Pharmacy' and the specific Lot and BUD (Beyond Use Date) information.
For Albumin Eye Drop 10%, check for NDC 44206-0251-05 with lot 03042020@28 (BUD 03/18/2020) or lot 03032020@3 (BUD 03/17/2020).
For Vancomycin Opthal 14 mg drops, check for NDC 67457-0340-01 with lot 03042020@7 (BUD 03/18/2020).
For Morphine 2 mg/mL Cassette (100 mL), check for NDC 00409-1134-03 with lot 03032020@34 (BUD 03/17/2020).
For Gentamicin/Bacitracin Bladder Irrigation, check for NDC 63323-0010-02 with lot 03022020@3 (BUD 03/16/2020); for Mitomycin 0.04% eye drops, check for NDC 67457-0518-05 with lot 03022020@5 (BUD 03/16/2020).
Immediately stop using any affected product and contact your healthcare provider or pharmacist for guidance on replacement therapy.
Return any unused portions of these specific lots to Medical Center Pharmacy at 2401 N Ocoee St, Cleveland, Tennessee, 37311 for a refund.
For further information or to report a concern, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Contact healthcare provider and return product to pharmacy.

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

Affected Products

Product: Albumin Eye Drop 10% S (10 mL bottle)

Model:

NDC 44206-0251-05

Lot Numbers:

03042020@28 (BUD: 03/18/2020)

03032020@3 (BUD: 03/17/2020)

Date Ranges: 03/17/2020, 03/18/2020

Product: Vancomycin Opthal 14 mg drops (5 mL bottle)

Model:

NDC 67457-0340-01

Lot Numbers:

03042020@7 (BUD: 03/18/2020)

Date Ranges: 03/18/2020

Product: Morphine 2 mg/mL Cassette (100 mL CADD Cassette)

Model:

NDC 00409-1134-03

Lot Numbers:

03032020@34 (BUD: 03/17/2020)

Date Ranges: 03/17/2020

Product: Gentamicin/Bacitracin Bladder Irrigation in N.S. (250 mL bags)

Model:

NDC 63323-0010-02

Lot Numbers:

03022020@3 (BUD: 03/16/2020)

Date Ranges: 03/16/2020

Product: Mitomycin 0.04% Ophth DR eye drops (5 mL bottle)

Model:

NDC 67457-0518-05

Lot Numbers:

03022020@5 (BUD: 03/16/2020)

Date Ranges: 03/16/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85217

Status: Resolved

Manufacturer: Medical Center Pharmacy, Inc.

Sold By: Medical Center Pharmacy, Inc.

Manufactured In: United States

Units Affected: 5 products (2 bottles; 1 bottle; 1 cassette; 2 bags; 2 bottles)

Distributed To: Tennessee

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

Identify if you have any of the affected medications by checking the product labels for the name 'Medical Center Pharmacy' and the specific Lot and BUD (Beyond Use Date) information.

For Albumin Eye Drop 10%, check for NDC 44206-0251-05 with lot 03042020@28 (BUD 03/18/2020) or lot 03032020@3 (BUD 03/17/2020).

For Vancomycin Opthal 14 mg drops, check for NDC 67457-0340-01 with lot 03042020@7 (BUD 03/18/2020).

For Morphine 2 mg/mL Cassette (100 mL), check for NDC 00409-1134-03 with lot 03032020@34 (BUD 03/17/2020).

For Gentamicin/Bacitracin Bladder Irrigation, check for NDC 63323-0010-02 with lot 03022020@3 (BUD 03/16/2020); for Mitomycin 0.04% eye drops, check for NDC 67457-0518-05 with lot 03022020@5 (BUD 03/16/2020).

Immediately stop using any affected product and contact your healthcare provider or pharmacist for guidance on replacement therapy.

Return any unused portions of these specific lots to Medical Center Pharmacy at 2401 N Ocoee St, Cleveland, Tennessee, 37311 for a refund.

For further information or to report a concern, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Albumin Eye Drop 10% S (10 mL bottle)

Model:

NDC 44206-0251-05

Lot Numbers:

03042020@28 (BUD: 03/18/2020)

03032020@3 (BUD: 03/17/2020)

Date Ranges: 03/17/2020, 03/18/2020

Product: Vancomycin Opthal 14 mg drops (5 mL bottle)

Model:

NDC 67457-0340-01

Lot Numbers:

03042020@7 (BUD: 03/18/2020)

Date Ranges: 03/18/2020

Product: Morphine 2 mg/mL Cassette (100 mL CADD Cassette)

Model:

NDC 00409-1134-03

Lot Numbers:

03032020@34 (BUD: 03/17/2020)

Date Ranges: 03/17/2020

Product: Gentamicin/Bacitracin Bladder Irrigation in N.S. (250 mL bags)

Model:

NDC 63323-0010-02

Lot Numbers:

03022020@3 (BUD: 03/16/2020)

Date Ranges: 03/16/2020

Product: Mitomycin 0.04% Ophth DR eye drops (5 mL bottle)

Model:

NDC 67457-0518-05

Lot Numbers:

03022020@5 (BUD: 03/16/2020)

Date Ranges: 03/16/2020