Drug product
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60) and b) 100-count bottles (NDC 59746-317-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
D-0671-2017
Product summary
- Event
- Event 76982
- Status
- Terminated
- Classification
- Class III
- Quantity
- 19,682 bottles
- Official record key
drug-enforcement:D-0671-2017
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) BU34002A, BU34003A, Exp 11/16; b) BU34001A, Exp 10/16
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
out of specification