Quetiapine Tablet, Film Coated, Extended Release
FDA Recall NDC 0904-6801
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Quetiapine (NDC 0904-6801). A significant event, classified as Class III, was initiated on Feb 27, 2020 by Major Pharmaceuticals. The reported reason for this action was: "Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
February 2020 Class III Recall: Labeling; Incorrect or Missing Package Insert
Recall Number
Class III Terminated
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Feb 27, 2020
Mar 18, 2020
115 cartons
Recall Profile & Regulatory Data
Event ID
85138
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
The Harvard Drug Group
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 24, 2022
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
Batch or Lot Expiration Information
Lot# Lot, expiry: Lot N00037, exp 05/2021
Affected Packages Involved in this Recall
0904-6801-61Product
0904-6802-61Product
0904-6803-61Product
0904-6804-61Product
0904-6805-61Product
February 2020 Class III Recall: Labeling; Incorrect or Missing Package Insert
Recall Number
Class III Terminated
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Feb 27, 2020
Mar 18, 2020
N/A
Recall Profile & Regulatory Data
Event ID
85138
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
The Harvard Drug Group
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 24, 2022
Product Description
Quetiapine Fumarate Extended-Release Tablets, 300 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: 0904-6804-61
Batch or Lot Expiration Information
Lot# Lot, expiry: Lot N00037, exp 05/2021
Affected Packages Involved in this Recall
0904-6801-61Product
0904-6802-61Product
0904-6803-61Product
0904-6804-61Product
0904-6805-61Product
February 2020 Class III Recall: Labeling; Incorrect or Missing Package Insert
Recall Number
Class III Terminated
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Feb 27, 2020
Mar 18, 2020
330 cartons
Recall Profile & Regulatory Data
Event ID
85138
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
The Harvard Drug Group
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 24, 2022
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
Batch or Lot Expiration Information
Lot# Lot, expiry: Lot N00028, exp 04/2021; Lot N00044, exp 06/2021
Affected Packages Involved in this Recall
0904-6801-61Product
0904-6802-61Product
0904-6803-61Product
0904-6804-61Product
0904-6805-61Product
February 2020 Class III Recall: Labeling; Incorrect or Missing Package Insert
Recall Number
Class III Terminated
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Feb 27, 2020
Mar 18, 2020
1 carton
Recall Profile & Regulatory Data
Event ID
85138
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
The Harvard Drug Group
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 24, 2022
Product Description
Quetiapine Fumarate Extended-Release Tablets, 150 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: 0904-6802-61
Batch or Lot Expiration Information
Lot# Lot, expiry: Lot N00036, exp 05/2021
Affected Packages Involved in this Recall
0904-6801-61Product
0904-6802-61Product
0904-6803-61Product
0904-6804-61Product
0904-6805-61Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
