FDA-Drug2018-04-11Class III
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
InvaGen Pharmaceuticals, Inc.
Hazard
Failed Dissolution Specifications; during stability testing
Sold states
Nationwide
Affected count
N/A
Manufactured in
7 Oser Ave, N/A, Hauppauge, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0619-2018Don't want to check this manually?
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