FDAFDA · Food and drugs·Recall number D-0519-2019
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
Published March 13, 2019 · Recall initiated: February 28, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications; 9-monthstability timepoint
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Jubilant Cadista Pharmaceuticals, Inc.
- Distributor
- Product was distributed to one customer who may have further distributed the product.
- Lot
- a) BR117002C, exp. date 11/2019; b) BR117003B and BR117004B, exp. date 11/2019
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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