FDA Drug recall D-0670-2017
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) and b) 100-count bot…
- FDA Drug
- Class III
- terminated
- Published 2017-04-19
On 2017-04-19 the FDA classified a Class III recall of BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) and b) 100-count bot… by Jubilant Cadista Pharmaceuticals, citing failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0670-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-04-08 |
| Published | 2017-04-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Jubilant Cadista Pharmaceuticals |
| Distribution | US |
Product
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
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0670-2017%22
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