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Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one ca...

FDA Recall #D-0584-2024 — Class II — June 18, 2024

Recall #D-0584-2024 Date: June 18, 2024 Classification: Class II Status: Terminated

Product Description

Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Major Pharmaceutical 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, USA, NDC 0904-7075-61, UPC code: 309047075614

Reason for Recall

Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.

Recalling Firm

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — La Vergne, TN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

864 cartons

Distribution

Nationwide. No foreign consignees.

Code Information

Lot code: M04614, Exp 09/30/2024

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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