The Harvard Drug Group recalls Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin…

Recall date

February 27, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0999-2020

FDA classification

Class III

Brand / firm

The Harvard Drug Group

Sold / distributed

Nationwide

Why it was recalled

Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6801-61