Medications & Supplements/Prescription Drugs

Hetero Labs Limited Unit V: Valganciclovir and Valacyclovir Tablets Recalled for Temperature Abuse

Agency Publication Date: March 16, 2018

Summary

Approximately 49,896 bottles of Valganciclovir (450 mg) and Valacyclovir (1 gram) prescription tablets are being recalled because they were exposed to high temperatures during shipping at an airport or in cargo. This exposure to excessive heat could potentially reduce the effectiveness of the medication or cause the drug to break down. Affected products were distributed nationwide in the United States after initially being sent to New Jersey. Consumers who have these medications should contact their healthcare provider or pharmacist for guidance on obtaining a safe replacement.

Risk

The medications were exposed to temperatures higher than the recommended storage limits during transit. This 'temperature abuse' can compromise the chemical stability and potency of the drugs, meaning they may not work as intended to treat viral infections.

What You Should Do

Check your medication bottles for Valganciclovir Tablets USP 450 mg (60-count) with NDC 31722-832-60 and lot numbers VGC17040 or VGC17041 with expiration date 07/2019.
Check your medication bottles for Valacyclovir Tablets USP 1 gram (30-count) with NDC 31722-705-30 and lot number VLC17027 with expiration date 07-2019.
If you have an affected bottle, contact your healthcare provider or pharmacist immediately to discuss your treatment and how to obtain a replacement.
Return any unused or affected medication to the pharmacy where you purchased it for a refund and to ensure proper disposal.
Contact the manufacturer, Hetero Labs Limited, for further instructions regarding this recall.
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

Pharmacy refund and healthcare consultation

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

Affected Products

Product: Valganciclovir Tablets, USP, 450 mg (60-count bottle)

Model:

NDC 31722-832-60

Recall #: D-0601-2018

Lot Numbers:

VGC17040 (Exp 07/2019)

VGC17041 (Exp 07/2019)

Date Ranges: EXP 07/2019

Product: Valacyclovir Tablets USP 1 gram (30-count bottle)

Model:

NDC 31722-705-30

Recall #: D-0602-2018

Lot Numbers:

VLC17027 (Exp 07-2019)

Date Ranges: Exp 07-2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79142

Status: Resolved

Manufacturer: Hetero Labs Limited Unit V

Sold By: Camber Pharmaceuticals, Inc.; Pharmacies nationwide

Manufactured In: India

Units Affected: 2 products (1764 60-count bottles; 48132 60-count bottles)

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 bottles for Valganciclovir Tablets USP 450 mg (60-count) with NDC 31722-832-60 and lot numbers VGC17040 or VGC17041 with expiration date 07/2019.

Check your medication bottles for Valacyclovir Tablets USP 1 gram (30-count) with NDC 31722-705-30 and lot number VLC17027 with expiration date 07-2019.

If you have an affected bottle, contact your healthcare provider or pharmacist immediately to discuss your treatment and how to obtain a replacement.

Return any unused or affected medication to the pharmacy where you purchased it for a refund and to ensure proper disposal.

Contact the manufacturer, Hetero Labs Limited, for further instructions regarding this recall.

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

Affected Products

Product: Valganciclovir Tablets, USP, 450 mg (60-count bottle)

Model:

NDC 31722-832-60

Recall #: D-0601-2018

Lot Numbers:

VGC17040 (Exp 07/2019)

VGC17041 (Exp 07/2019)

Date Ranges: EXP 07/2019

Product: Valacyclovir Tablets USP 1 gram (30-count bottle)

Model:

NDC 31722-705-30

Recall #: D-0602-2018

Lot Numbers:

VLC17027 (Exp 07-2019)

Date Ranges: Exp 07-2019