US Drug Recall Register
Class III · Low risk Terminated Initiated Mar 15, 2018 (8 years ago)

buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Failed Dissolution Specifications; during stability testing

What was recalled

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

Recalling firm
InvaGen Pharmaceuticals, Inc.
NDC code
69097-878-03
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0619-2018

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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