Medications & Supplements/Prescription Drugs

Medisca, Inc.: Aminocaproic Acid Recalled for Improper Industrial Labeling

Agency Publication Date: September 20, 2017

Summary

Medisca, Inc. is recalling approximately 34,600 grams of Aminocaproic Acid, USP (6-Aminohexanoic Acid), an active pharmaceutical ingredient used in pharmacy compounding. The product was manufactured for industrial use but was incorrectly labeled and distributed as being suitable for pharmaceutical use. This deviation from manufacturing standards means the product may not meet the safety or quality requirements for human medication. If you have been prescribed a medication containing this ingredient, you should contact your healthcare provider or pharmacist.

Risk

Because this product was produced for industrial use, it was not subject to the strict safety and quality controls required for human drugs. This poses a risk that the ingredient could contain impurities or have chemical properties unsuitable for medical treatment, potentially leading to unpredictable health effects.

What You Should Do

Check your medication records or contact your pharmacist to see if your compounded medication used Aminocaproic Acid from Medisca, Inc. with NDC numbers 38779-0989-05, 38779-0989-09, or 38779-0989-07.
Verify the lot numbers and expiration dates on the packaging: Look for lot numbers 143595/A, 143595/B, or 143595/D with an expiration date of 02/28/20.
If you are a pharmacy or healthcare provider, stop using these specific lots immediately and quarantine any remaining stock.
Patients who believe they have received medication made with this affected ingredient should contact their healthcare provider or pharmacist for guidance regarding their treatment.
Return any unused product to the place of purchase for a refund and contact Medisca, Inc. for further instructions.
For more information or to report concerns, 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 unused product for a refund.

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

Affected Products

Product: Aminocaproic Acid, USP (6-Aminohexanoic Acid) (100 g jar)

Model:

NDC 38779-0989-05

Lot Numbers:

143595/A (Exp 02/28/20)

143595/B (Exp 02/28/20)

143595/D (Exp 02/28/20)

Date Ranges: Exp 02/28/20

Product: Aminocaproic Acid, USP (6-Aminohexanoic Acid) (1 kg jar)

Model:

NDC 38779-0989-09

Lot Numbers:

143595/A (Exp 02/28/20)

143595/B (Exp 02/28/20)

143595/D (Exp 02/28/20)

Date Ranges: Exp 02/28/20

Product: Aminocaproic Acid, USP (6-Aminohexanoic Acid) (25 kg drum)

Model:

NDC 38779-0989-07

Lot Numbers:

143595/A (Exp 02/28/20)

143595/B (Exp 02/28/20)

143595/D (Exp 02/28/20)

Date Ranges: Exp 02/28/20

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78123

Status: Resolved

Manufacturer: Medisca, Inc.

Sold By: Pharmacy compounders; Hospitals

Manufactured In: United States

Units Affected: 34,600 g

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

Risk

What You Should Do

Check your medication records or contact your pharmacist to see if your compounded medication used Aminocaproic Acid from Medisca, Inc. with NDC numbers 38779-0989-05, 38779-0989-09, or 38779-0989-07.

Verify the lot numbers and expiration dates on the packaging: Look for lot numbers 143595/A, 143595/B, or 143595/D with an expiration date of 02/28/20.

If you are a pharmacy or healthcare provider, stop using these specific lots immediately and quarantine any remaining stock.

Patients who believe they have received medication made with this affected ingredient should contact their healthcare provider or pharmacist for guidance regarding their treatment.

Return any unused product to the place of purchase for a refund and contact Medisca, Inc. for further instructions.

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

Affected Products

Product: Aminocaproic Acid, USP (6-Aminohexanoic Acid) (100 g jar)

Model:

NDC 38779-0989-05

Lot Numbers:

143595/A (Exp 02/28/20)

143595/B (Exp 02/28/20)

143595/D (Exp 02/28/20)

Date Ranges: Exp 02/28/20

Product: Aminocaproic Acid, USP (6-Aminohexanoic Acid) (1 kg jar)

Model:

NDC 38779-0989-09

Lot Numbers:

143595/A (Exp 02/28/20)

143595/B (Exp 02/28/20)

143595/D (Exp 02/28/20)

Date Ranges: Exp 02/28/20

Product: Aminocaproic Acid, USP (6-Aminohexanoic Acid) (25 kg drum)

Model:

NDC 38779-0989-07

Lot Numbers:

143595/A (Exp 02/28/20)

143595/B (Exp 02/28/20)

143595/D (Exp 02/28/20)

Date Ranges: Exp 02/28/20