FDAClass IIIOctober 10, 2012

buPROPion Hydrochloride Extended-Release Tablets recall: Failed Dissolution

buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury…

Why was buPROPion Hydrochloride Extended-Release Tablets recalled?

Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.

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 #: 0075375, 0074584, Exp 08/12

Product
buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury…
Recalling firm
McKesson Packaging Services
Quantity
674 cartons
Distribution
Nationwide
Recall date
October 10, 2012
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls