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Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 6800...

FDA Recall #D-0137-2017 — Class III — October 27, 2016

Recall #D-0137-2017 Date: October 27, 2016 Classification: Class III Status: Terminated

Product Description

Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories

Reason for Recall

Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.

Recalling Firm

Amerisource Health Services — Columbus, OH

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

a) 15,409 bottles b) 5,128 bottles

Distribution

Nationwide and Puerto Rico

Code Information

Lot #: a) M601509, Exp 3/31/2018; M606506, Exp 4/30/2018; b) M601510, Exp 3/31/2018; M604444, Exp 4/30/2018; M606515, Exp 4/30/2018.

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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