Reported Feb 5, 2014 · Terminated
BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count…
Actavis Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Actavis Inc · 400 Interpace Pkwy · Parsippany, NJ · 07054-1120
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 30 count bottle(NDC 0591-3331-30) |
| 2 | 90 count bottle (NDC 0591-3331-19) |
| 3 | 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laboratories, Inc. Corona, CA 92880 |
- Lot codes and dates
- Lots
524099M524100A521687A
- Lots
- Amount recalled
- 139,944 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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