D-0670-2017 Class III Terminated
FDA drug recall D-0670-2017 was initiated by Jubilant Cadista Pharmaceuticals, Inc. on Apr 8, 2016 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid. The recall status is terminated (terminated Apr 17, 2017). Affected quantity: 81,077 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 19, 2017
- Initiation Date
- Apr 8, 2016
- Termination Date
- Apr 17, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 81,077 bottles
Product Description
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 by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
Reason for Recall
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #s: a) BU25001A, Exp 12/16; BU25002A, BU25003A, BU25004A, Exp 01/17; b) BU24003A, Exp 10/16; BU24004A, BU24005A, Exp 11/16; BU25005A, Exp 01/17
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0670-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026