BuPROPion Hydrochloride Extended-Release Tablet recall: Failed Dissolution
BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c)…
Why was BuPROPion Hydrochloride Extended-Release Tablet recalled?
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
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: 524099M, 524100A, 521687A
- Product
- BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c)…
- Recalling firm
- Actavis Inc
- Quantity
- 139,944 bottles
- Distribution
- Nationwide and Puerto Rico
- Recall date
- February 5, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)