BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30...
FDA Recall #D-0519-2019 — Class III — February 28, 2019
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
Recalling Firm
Jubilant Cadista Pharmaceuticals, Inc. — Salisbury, MD
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
a) 3,072 bottles; b) 2,688 bottles
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated