InvaGen Pharmaceuticals, Inc. recalls buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-
Recalled April 11, 2018 · FDA recall D-0619-2018 · InvaGen Pharmaceuticals
Hazard
Failed Dissolution Specifications; during stability testing · FDA Class III
Units
N/A
Sold at
Nationwide
Description
Failed Dissolution Specifications; during stability testing
Product
buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-878-07) 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
Manufacturer(s)
InvaGen Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →