Recalls / Class III
Class IIID-0519-2019
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
- Affected lot / code info
- a) BR117002C, exp. date 11/2019; b) BR117003B and BR117004B, exp. date 11/2019
Why it was recalled
Failed Dissolution Specifications; 9-monthstability timepoint
Recalling firm
- Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 207 Kiley Dr, N/A, Salisbury, Maryland 21801-2249
Distribution
- Quantity
- a) 3,072 bottles; b) 2,688 bottles
- Distribution pattern
- Product was distributed to one customer who may have further distributed the product.
Timeline
- Recall initiated
- 2019-02-28
- FDA classified
- 2019-03-06
- Posted by FDA
- 2019-03-13
- Terminated
- 2020-03-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0519-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.