FDAClass IIIJuly 27, 2016

buPROPion Hydrochloride Extended Release Tablets USP recall: Failed Dissolution

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

Why was buPROPion Hydrochloride Extended Release Tablets USP recalled?

Failed Dissolution Specifications

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot JKN3477A, exp 07/2016

Product
buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol 389-350 Gujarat India ---- NDC 47335-737-86
Recalling firm
Sun Pharmaceutical Industries, Inc.
Quantity
16,085 bottles
Distribution
Nationwide
Recall date
July 27, 2016
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls