Medications & Supplements/Prescription Drugs

Lowlite Investments, Inc. D/B/A Olympia Pharmacy: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Agency Publication Date: July 12, 2013

Summary

Lowlite Investments, Inc. D/B/A Olympia Pharmacy is recalling one unit of Diclazuril 10 mg/ml Injection compounded in Orlando, Florida. This voluntary recall was initiated due to a lack of assurance of sterility following FDA inspection findings that raised concerns about quality control processes. The affected product is identified by lot number B5014 with an expiration date of 8/14/13.

Risk

The lack of sterility assurance in an injectable medication can lead to serious systemic infections or localized abscesses at the injection site. Because this product is intended for injection, any microbial contamination poses a direct risk of introducing pathogens into the body.

What You Should Do

Check the label of your Diclazuril 10 mg/ml Injection for lot number B5014 and expiration date 8/14/13 to determine if your product is affected.
Identify if you have the product compounded by Olympia Pharmacy in Orlando, FL, as this is the specific manufacturer involved.
Contact Olympia Pharmacy or your healthcare provider immediately for instructions on how to handle the affected unit, as no specific disposal or return remedy was provided in the initial report.
For further information or to report adverse events, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Diclazuril 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL

Lot Numbers:

B5014 (Exp 8/14/13)

Date Ranges: Expiration 8/14/13

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 65360

Status: Active

Manufacturer: Lowlite Investments, Inc. D/B/A Olympia Pharmacy

Manufactured In: United States

Units Affected: 105 products (1; 1; 1; 5; 1; 2; 1; 1; 1; 3; 1; 1; 1; 1; 4; 1; 3; 1; 1; 1; 1; 2; 1; 1; 2; 2; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 1; 2; 1; 1; 1; 3; 1; 2; 3; 2; 1; 1; 2; 1; 1; 1; 1; 1; 1; 1; 2; 1; 2; 1; 1; 2; 1; 1; 3; 1; 1; 1; 3; 6; 1; 1; 3; 1; 5; 1; 4; 6; 1; 1; 1; 1; 3; 1; 1; 1; 10; 3; 2; 1; 2; 24; 2; 1; 1; 2; 1; 1; 1; 1; 1)

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 the label of your Diclazuril 10 mg/ml Injection for lot number B5014 and expiration date 8/14/13 to determine if your product is affected.

Identify if you have the product compounded by Olympia Pharmacy in Orlando, FL, as this is the specific manufacturer involved.

Contact Olympia Pharmacy or your healthcare provider immediately for instructions on how to handle the affected unit, as no specific disposal or return remedy was provided in the initial report.

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