Why it was recalled
Failed Dissolution Specifications; 9-monthstability timepoint
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
Lot numbers, UPCs & expiration codes
a) BR117002C, exp. date 11/2019; b) BR117003B and BR117004B, exp. date 11/2019
Where it was sold
Product was distributed to one customer who may have further distributed the product.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0519-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 28, 2019
- FDA report date
- Mar 13, 2019
- Quantity
- a) 3,072 bottles; b) 2,688 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0519-2019, exactly as published.
Show all FDA fields
- City
- Salisbury
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 82280
- Address
- 207 Kiley Dr
- Code information
- a) BR117002C, exp. date 11/2019; b) BR117003B and BR117004B, exp. date 11/2019
- Postal code
- 21801-2249
- Report date
- Mar 13, 2019
- Product type
- Drugs
- Recall number
- D-0519-2019
- Classification
- Class III
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Product quantity
- a) 3,072 bottles; b) 2,688 bottles
- Termination date
- Mar 5, 2020
- Reason for recall
- Failed Dissolution Specifications; 9-monthstability timepoint
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed to one customer who may have further distributed the product.
- Recall initiation date
- Feb 28, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 6, 2019