Medications & Supplements/Prescription Drugs

Apace KY LLC: Acyclovir Tablets Recalled for Potential Presence of Foreign Medication

Agency Publication Date: February 23, 2018

Summary

Apace KY LLC is recalling approximately 630 cartons of Acyclovir (acyclovir) 400 mg tablets because some packages may contain Torsemide tablets instead of the intended medication. Torsemide is a prescription diuretic, and its unintended consumption can lead to serious health issues. The affected medication was manufactured for AvKARE, Inc. and distributed nationwide in the United States.

Risk

If a patient inadvertently takes Torsemide instead of Acyclovir, they may experience excessive urination, dehydration, or dangerous electrolyte imbalances. Patients with pre-existing kidney or heart conditions are at higher risk for severe complications from unintended diuretic use.

What You Should Do

Check your medication cartons for Acyclovir Tablets, USP, 400 mg with Lot number 19900 and an expiration date of 05/2019.
Verify the NDC numbers on your packaging: the individual unit dose blisters should be NDC 50268-061-11 and the outer carton should be NDC 50268-061-15.
Immediately contact your healthcare provider or pharmacist if you suspect you have received or consumed the wrong medication.
Return any unused product from the affected lot to your pharmacy to receive a refund.
Contact the manufacturer, Apace KY LLC, for further instructions regarding the return of these tablets.
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 consultation and product return

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

Affected Products

Product: Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters

Model:

NDC 50268-061-11 (blister)

NDC 50268-061-15 (carton)

D-0544-2018

Lot Numbers:

19900 (Exp 05/2019)

Date Ranges: Exp 05/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79194

Status: Resolved

Manufacturer: Apace KY LLC

Sold By: AvKARE, Inc.

Manufactured In: United States

Units Affected: 630 cartons

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 cartons for Acyclovir Tablets, USP, 400 mg with Lot number 19900 and an expiration date of 05/2019.

Verify the NDC numbers on your packaging: the individual unit dose blisters should be NDC 50268-061-11 and the outer carton should be NDC 50268-061-15.

Immediately contact your healthcare provider or pharmacist if you suspect you have received or consumed the wrong medication.

Return any unused product from the affected lot to your pharmacy to receive a refund.

Contact the manufacturer, Apace KY LLC, for further instructions regarding the return of these tablets.

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