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Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmac...

FDA Recall #D-0045-2025 — Class III — November 5, 2024

Recall #D-0045-2025 Date: November 5, 2024 Classification: Class III Status: Terminated

Product Description

Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA, NDC 0904-6441-61.

Reason for Recall

Failed Impurities/Degradation Specifications; during routine stability testing for impurities.

Recalling Firm

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

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

25814 tablets

Distribution

Nationwide in the US.

Code Information

Lot#: T04888, Exp 11/2024; T04946, Exp 12/2024; T04970, Exp 07/2025

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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