Medications & Supplements/Prescription Drugs

Major Pharmaceuticals Venlafaxine Capsules Recalled for Dissolution Failure

Agency Publication Date: July 3, 2024

Summary

Major Pharmaceuticals and Rugby Laboratories have recalled 864 cartons of Venlafaxine Hydrochloride (venlafaxine) extended-release capsules, USP, 37.5mg. This prescription antidepressant is being recalled because routine stability testing revealed the drug was dissolving faster than specifications allow. The affected products were distributed nationwide in 10 x 10 blister cards within a carton.

Risk

If an extended-release medication dissolves too quickly, the patient may receive too much of the drug at once, which could lead to an increased risk of side effects or reduce the intended therapeutic effect over time.

What You Should Do

This recall affects Venlafaxine Hydrochloride, extended-release capsules (37.5mg) sold in 10 x 10 blister cards under Major Pharmaceutical and Rugby Laboratories distribution with NDC 0904-7075-61 and UPC code 309047075614.
Identify affected products by checking for lot code M04614 with an expiration date of 09/30/2024.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg (10 x 10 blister card in one carton)

Variants: 37.5mg, Extended-release capsules

UPC Codes:

309047075614

Lot Numbers:

M04614 (Exp 09/30/2024)

NDC:

0904-7075-61

Manufactured by Cadila Healthcare Ltd., Ahmedabad, India; Distributed by Major Pharmaceutical and Rugby Laboratories.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94835

Status: Resolved

Manufacturer: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Sold By: Pharmacies

Manufactured In: India

Units Affected: 864 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 Venlafaxine Hydrochloride, extended-release capsules (37.5mg) sold in 10 x 10 blister cards under Major Pharmaceutical and Rugby Laboratories distribution with NDC 0904-7075-61 and UPC code 309047075614.

Identify affected products by checking for lot code M04614 with an expiration date of 09/30/2024.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

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

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: Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg (10 x 10 blister card in one carton)

Variants: 37.5mg, Extended-release capsules

UPC Codes:

309047075614

Lot Numbers:

M04614 (Exp 09/30/2024)

NDC:

0904-7075-61

Manufactured by Cadila Healthcare Ltd., Ahmedabad, India; Distributed by Major Pharmaceutical and Rugby Laboratories.