Drug 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.
D-0670-2017
Product summary
- Event
- Event 76982
- Status
- Terminated
- Classification
- Class III
- Quantity
- 81,077 bottles
- Official record key
drug-enforcement:D-0670-2017
Official wording
Reason: Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
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
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
out of specification