The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1001-2020·Announced 2020-03-18

Quetiapine Fumarate Extended-Release Tablets Recalled for Incorrect Package Insert

The Harvard Drug Group is recalling 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 low severity (score 1 or 2) because it is unlikely to cause adverse health consequences. The issue is a packaging/labeling error.

Plain-English summary

The Harvard Drug Group is recalling 115 cartons of Quetiapine Fumarate Extended-Release Tablets, 200 mg. The affected product is identified by Lot N00037 with an expiration date of 05/2021. The product was distributed nationwide.

The recall was initiated because the product was packaged with the package insert for Quetiapine Fumarate Tablets instead of the correct insert for Quetiapine Fumarate Extended-Release Tablets. This labeling error is classified as FDA Class III, indicating it is not likely to cause adverse health consequences.

Consumers and healthcare providers should check their inventory for the specific lot and expiration date listed above. If found, the product should be returned to the distributor or disposed of according to local regulations.

The recalled product

Product
QUETIAPINE (QUETIAPINE)
Brand
QUETIAPINE
Manufacturer
The Harvard Drug Group
Category
Drug — Prescription Drug
Hazard
Affected units
115

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 (3)

  • Lot
  • expiry: Lot N00037
  • exp 05/2021

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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Same hazard · mis labeling

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