buPROPion Hydrochloride Extended-release Tablets recall: Failed Dissolution
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-0738-86
Why was buPROPion Hydrochloride Extended-release Tablets recalled?
Failed Dissolution Specifications; 18 month stability time 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?
JKP0905A 04/17
- Product
- buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-0738-86
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Quantity
- 11,618 bottles
- Distribution
- Nationwide
- Recall date
- February 1, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)