Reported Apr 19, 2017 · Terminated
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60)…
Jubilant Cadista Pharmaceuticals, 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: Jubilant Cadista Pharmaceuticals, Inc. · 207 Kiley Dr · Salisbury, MD · 21801-2249
Is this the product you have?
- BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) and b) 100-count bottles (NDC 59746-316-01), Rx only
- Manufactured byJulibant Life Sciences Ltd., Roorkee-247661, India
- Marketed byJubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA
- Lot codes and dates
Lot #s: a) BU25001AExp 12/16BU25002ABU25003ABU25004AExp 01/17b) BU24003AExp 10/16BU24004ABU24005AExp 11/16BU25005AExp 01/17
- Amount recalled
- 81,077 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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