Medications & Supplements/Prescription Drugs

Hetero Labs Limited Unit V: Famciclovir Tablets Recalled for Tablet Coating Damage and Moisture

Agency Publication Date: February 13, 2018

Summary

Hetero Labs Limited Unit V has recalled 8,436 bottles of Famciclovir (500 mg), a prescription medication used to treat viral infections. The recall was initiated because the tablets were exposed to high temperatures during distribution, causing them to become wet, stick together, and have their protective coatings peel or disintegrate. This recall affects 30-count bottles manufactured for Camber Pharmaceuticals and distributed nationwide in the USA.

Risk

Exposure to high heat and moisture can degrade the medication and damage its protective coating, which may affect how the drug is absorbed by the body or reduce its effectiveness. This temperature abuse physically alters the tablets, making them appear wet and clumped together.

What You Should Do

Check your prescription bottle to see if you have Famciclovir Tablets, 500 mg (30-count bottles) manufactured for Camber Pharmaceuticals with NDC 31722-708-30.
Verify the bottle for lot number FMC17039 with an expiration date of 07/2019.
Inspect the tablets inside the bottle; if they appear wet, are stuck together, or have peeling or disintegrated coatings, do not use them.
Contact your healthcare provider or pharmacist for guidance regarding your treatment and to obtain a replacement prescription if necessary.
Return any unused product from the affected lot to your pharmacy for a refund.
Contact Hetero Labs Limited or Camber Pharmaceuticals for further instructions regarding this recall.
For additional questions or to report a problem, 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 pharmacy refund

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

Affected Products

Product: Famciclovir Tablets, 500 mg (30-count bottles)

Model:

NDC 31722-708-30

Lot Numbers:

FMC17039 (Exp 07/2019)

Date Ranges: 07/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78811

Status: Resolved

Manufacturer: Hetero Labs Limited Unit V

Sold By: Camber Pharmaceuticals. Inc.

Manufactured In: India

Units Affected: 8,436 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 prescription bottle to see if you have Famciclovir Tablets, 500 mg (30-count bottles) manufactured for Camber Pharmaceuticals with NDC 31722-708-30.

Verify the bottle for lot number FMC17039 with an expiration date of 07/2019.

Inspect the tablets inside the bottle; if they appear wet, are stuck together, or have peeling or disintegrated coatings, do not use them.

Contact your healthcare provider or pharmacist for guidance regarding your treatment and to obtain a replacement prescription if necessary.

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

Contact Hetero Labs Limited or Camber Pharmaceuticals for further instructions regarding this recall.

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