Drug product
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles, Rx only, Manufactured b Jubilant Generis Ltd, Roorkee, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD
D-0519-2019
Product summary
- Event
- Event 82280
- Status
- Terminated
- Classification
- Class III
- Quantity
- a) 3,072 bottles; b) 2,688 bottles
- Official record key
drug-enforcement:D-0519-2019
Official wording
Reason: Failed Dissolution Specifications; 9-monthstability timepoint
Code information: a) BR117002C, exp. date 11/2019; b) BR117003B and BR117004B, exp. date 11/2019
Distribution pattern: Product was distributed to one customer who may have further distributed the product.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications