Medications & Supplements/Prescription Drugs

Solco Healtcare US LLC: Gabapentin Recalled Due to Dosage Labeling Mix-Up

Agency Publication Date: January 5, 2018

Summary

Solco Healthcare US LLC has issued a voluntary recall for one lot of Gabapentin Tablets, USP, 800 mg. Some bottles labeled as containing 800 mg tablets may actually contain 600 mg tablets. This dosage error could lead to patients receiving less medication than prescribed by their doctor, potentially resulting in inadequate treatment of their medical condition. Consumers should immediately check their medication bottles to see if their supply is part of the affected lot.

Risk

A labeling mix-up where 600 mg tablets are provided instead of 800 mg tablets causes patients to receive a lower dose of medication than intended, which may decrease the effectiveness of the treatment and fail to control symptoms.

What You Should Do

Check your Gabapentin 800 mg bottle for Lot Number 7700656A and NDC 43547-0333-50 to see if your medication is affected.
Verify if your bottle is a 500-count size labeled as Gabapentin Tablets, USP, 800 mg, distributed by Solco Healthcare US, LLC.
If your medication matches the affected lot, contact your healthcare provider or pharmacist immediately for guidance on how to continue your treatment safely.
Return any unused product from the affected lot to the pharmacy where you purchased it for a refund.
Contact Solco Healthcare US LLC at their office in Cranbury, NJ, for further instructions regarding this recall.
For additional questions or to report a problem, call 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 return

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

Affected Products

Product: Gabapentin Tablets, USP, 800 mg (500-count)

Model:

NDC 43547-0333-50

Recall #: D-0155-2018

PONDRUGS/16 134193

Lot Numbers:

7700656A

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78697

Status: Resolved

Manufacturer: Solco Healtcare US LLC

Sold By: Pharmacies

Manufactured In: India, United States

Distributed To: Ohio

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 Gabapentin 800 mg bottle for Lot Number 7700656A and NDC 43547-0333-50 to see if your medication is affected.

Verify if your bottle is a 500-count size labeled as Gabapentin Tablets, USP, 800 mg, distributed by Solco Healthcare US, LLC.

If your medication matches the affected lot, contact your healthcare provider or pharmacist immediately for guidance on how to continue your treatment safely.

Return any unused product from the affected lot to the pharmacy where you purchased it for a refund.

Contact Solco Healthcare US LLC at their office in Cranbury, NJ, for further instructions regarding this recall.

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