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
Reported: March 13, 2019 Initiated: February 28, 2019 #D-0519-2019
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
Details
- Recalling Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Units Affected
- a) 3,072 bottles; b) 2,688 bottles
- Distribution
- Product was distributed to one customer who may have further distributed the product.
- Location
- Salisbury, MD
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Jubilant Cadista Pharmaceuticals, Inc.. Units affected: a) 3,072 bottles; b) 2,688 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications; 9-monthstability timepoint
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 13, 2019. Severity: Low. Recall number: D-0519-2019.
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