FDA recall D-0618-2018

Product

buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 --- NDC 69097-877-03

Reason for recall

Failed Dissolution Specifications; during stability testing

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2018-03-15

Report date

2018-04-11

Termination date

2021-09-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hauppauge, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0618-2018