Class III
Terminated
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
This recall has been terminated (originally issued March 13, 2019).
- Recall Initiated
- February 28, 2019
- Posted
- March 13, 2019
- Recall Number
- D-0519-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 3,072 bottles; b) 2,688 bottles
- Firm Location
- Salisbury, MD, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specifications; 9-monthstability timepoint
Distribution
Product was distributed to one customer who may have further distributed the product.
Lot / Code Info
a) BR117002C, exp. date 11/2019; b) BR117003B and BR117004B, exp. date 11/2019
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