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Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, ...

FDA Recall #D-1001-2020 — Class III — February 27, 2020

Recall #D-1001-2020 Date: February 27, 2020 Classification: Class III Status: Terminated

Product Description

Quetiapine Fumarate Extended-Release Tablets, 200 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: 0904-6803-61

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

115 cartons

Distribution

Nationwide

Code Information

Lot, expiry: Lot N00037, exp 05/2021

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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