Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, M...
FDA Recall #D-0999-2020 — Class III — February 27, 2020
Product Description
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
Reason for Recall
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Recalling Firm
The Harvard Drug Group — Livonia, MI
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
330 cartons
Distribution
Nationwide
Code Information
Lot, expiry: Lot N00028, exp 04/2021; Lot N00044, exp 06/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated