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Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Di...

FDA Recall #D-0044-2024 — Class III — October 4, 2023

Recall #D-0044-2024 Date: October 4, 2023 Classification: Class III Status: Terminated

Product Description

Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-737-86

Reason for Recall

Failed Dissolution Specifications

Recalling Firm

SUN PHARMACEUTICAL INDUSTRIES INC — Princeton, NJ

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

144 bottles

Distribution

Nationwide in the USA.

Code Information

Lot #: HAD0360A, Exp. 12/2023

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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