D-1002-2020 Class III Terminated
FDA drug recall D-1002-2020 was initiated by The Harvard Drug Group on February 27, 2020 and is designated Class III. 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. The recall status is terminated (terminated September 24, 2022).
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
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
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 N00037, exp 05/2021