Medications & Supplements/Prescription Drugs

Major Pharmaceuticals Tramadol Tablets Recalled for Inadequate Packaging Seals

Agency Publication Date: June 26, 2023

Summary

The Harvard Drug Group is recalling 3,876 cartons of Major Pharmaceuticals Tramadol Hydrochloride (50 mg) tablets. This medication was manufactured by Sun Pharmaceutical Industries and is being recalled because the blister packaging was not properly sealed. If you have been prescribed this medication, you should consult with your pharmacist or doctor to determine if your tablets are affected and how to obtain a replacement.

Risk

A packaging defect that leaves blister packs inadequately sealed can expose the medication to environmental factors like moisture or oxygen. This can compromise the drug's stability, potentially leading to reduced effectiveness or accidental contamination.

What You Should Do

This recall affects 100-count unit dose cartons of Tramadol Hydrochloride Tablets, USP 50 mg, distributed under the Major Pharmaceuticals brand (NDC 0904-7179-61).
Identify the affected products by checking the packaging for lot number M04343 with an expiration date of 04/2024.
If you have health concerns about your medication, contact your healthcare provider or pharmacist immediately.
Return any unused product to the place of purchase for a refund, throw it away, or contact The Harvard Drug Group for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Tramadol Hydrochloride Tablets, USP (Unit Dose 100-Count)by Major Pharmaceuticals

Variants: 50 mg, Tablet

Lot Numbers:

M04343 (Exp. 04/2024)

NDC:

0904-7179-61

Manufactured by Sun Pharmaceutical Industries Ltd.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92524

Status: Resolved

Manufacturer: The Harvard Drug Group

Sold By: Major Pharmaceuticals; Sun Pharmaceutical Industries, Inc.; The Harvard Drug Group

Manufactured In: India, United States

Units Affected: 3876 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

This recall affects 100-count unit dose cartons of Tramadol Hydrochloride Tablets, USP 50 mg, distributed under the Major Pharmaceuticals brand (NDC 0904-7179-61).

Identify the affected products by checking the packaging for lot number M04343 with an expiration date of 04/2024.

If you have health concerns about your medication, contact your healthcare provider or pharmacist immediately.

Return any unused product to the place of purchase for a refund, throw it away, or contact The Harvard Drug Group for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.