buPROPrion Hydrochloride Extended-Release Tablets recall: Failed Dissolution
buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86
Why was buPROPrion Hydrochloride 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?
Lots: HAC2240A, Exp 05/2023; HAC3162A, Exp 07/2023
- Product
- buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Quantity
- 5,344 Bottles
- Distribution
- Nationwide in the U.S.A
- Recall date
- May 31, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)