Home / Recalls / The Harvard Drug Group / D-0999-2020

D-0999-2020 Class III Terminated

Recalled by The Harvard Drug Group — Livonia, MI

Recall Details

Product Type
Drugs
Report Date
March 18, 2020
Initiation Date
February 27, 2020
Termination Date
September 24, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
330 cartons

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.

Distribution Pattern

Nationwide

Code Information

Lot, expiry: Lot N00028, exp 04/2021; Lot N00044, exp 06/2021

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