D-0519-2019 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 13, 2019
- Initiation Date
- February 28, 2019
- Termination Date
- March 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 3,072 bottles; b) 2,688 bottles
Product Description
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
Reason for Recall
Failed Dissolution Specifications; 9-monthstability timepoint
Distribution Pattern
Product was distributed to one customer who may have further distributed the product.
Code Information
a) BR117002C, exp. date 11/2019; b) BR117003B and BR117004B, exp. date 11/2019