Reported Aug 13, 2014 · Terminated
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt…
Wockhardt USA 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: Wockhardt Usa Inc. · 20 Waterview Blvd., Suite 3 · Parsippany, NJ · 07054
Is this the product you have?
- buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only
- Manufactured byWockhardt Limited, Mumbai, India
- Distributed byWockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07
- Lot codes and dates
Lot #: DN10635Exp 01/15DM13402DN10247Exp 11/14and DM13449Exp 07/14
- Amount recalled
- 840 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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