Recall: D-0618-2018

Class III - Minor Violations

Class IIIClassification

2018-03-15Initiated

TerminatedStatus

InvaGen Pharmaceuticals, Inc.Firm

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

Failed Dissolution Specifications; during stability testing

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.