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.,

FDA recall notice · announced March 13, 2019 · Jubilant Cadista Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Reason for recall

Failed Dissolution Specifications; 9-monthstability timepoint

Notes

Distribution: Product was distributed to one customer who may have further distributed the product.
Lot/code information: a) BR117002C, exp. date 11/2019; b) BR117003B and BR117004B, exp. date 11/2019
Quantity: a) 3,072 bottles; b) 2,688 bottles
Status: Terminated
Products in this recall event:
- 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, Indi (D-0519-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.