FDAClass IIIApril 11, 2018

buPROPion HCl Extended-Release Tablets recall: Failed Dissolution

buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway…

Why was buPROPion HCl Extended-Release Tablets recalled?

Failed Dissolution Specifications; during stability testing

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# I1606579 and Lot# I1606580 Exp: 05/2018; Lot# I1612114 and Lot# I1612115 Exp: 11/2018

Product
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway…
Recalling firm
InvaGen Pharmaceuticals, Inc.
Quantity
N/A
Distribution
Nationwide
Recall date
April 11, 2018
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls