Recalls / Class III
Class IIID-0671-2017
Product
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60) and b) 100-count bottles (NDC 59746-317-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
- Affected lot / code info
- Lot #s: a) BU34002A, BU34003A, Exp 11/16; b) BU34001A, Exp 10/16
Why it was recalled
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Recalling firm
- Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 207 Kiley Dr, N/A, Salisbury, Maryland 21801-2249
Distribution
- Quantity
- 19,682 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2016-04-08
- FDA classified
- 2017-04-13
- Posted by FDA
- 2017-04-19
- Terminated
- 2017-04-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0671-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.