The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0999-2020·Announced 2020-03-18

Quetiapine Fumarate Extended-Release Tablets Recalled for Incorrect Package Insert

The Harvard Drug Group is recalling 330 cartons of Quetiapine Fumarate Extended-Release Tablets because they were packaged with the wrong package insert.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a packaging/labeling error involving the wrong package insert.

Plain-English summary

The Harvard Drug Group is recalling 330 cartons of Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton. The product is distributed nationwide and is manufactured by Lupin Limited in India and distributed by Major Pharmaceuticals in Livonia, Michigan. The specific lots involved are N00028 (exp 04/2021) and N00044 (exp 06/2021).

The recall was initiated because the product was packaged with the package insert for Quetiapine Fumarate Tablets rather than the correct insert for Quetiapine Fumarate Extended-Release Tablets. This labeling error means patients may not have received the specific instructions and safety information intended for the extended-release formulation.

Consumers who have this product should contact their healthcare provider or pharmacist for guidance. The recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

The recalled product

Product
QUETIAPINE (QUETIAPINE)
Brand
QUETIAPINE
Manufacturer
The Harvard Drug Group
Category
Drug — Prescription Drug
Hazard
Affected units
330

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Lot
  • expiry: Lot N00028
  • exp 04/2021
  • Lot N00044
  • exp 06/2021

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by The Harvard Drug Group under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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