Drug recall D-1001-2020
Product
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.
Lots and codes
Lot, expiry: Lot N00037, exp 05/2021
Recall details
- Recalling firm
- The Harvard Drug Group, Livonia, MI
- Quantity
- 115 cartons
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 27, 2020
- Terminated
- September 24, 2022
Related products
- Quetiapine – drug information
- NDC 0904-6802 Quetiapine · Quetiapine Fumarate 150 mg/1 · Major Pharmaceuticals
- NDC 0904-6805 Quetiapine · Quetiapine Fumarate 400 mg/1 · Major Pharmaceuticals
- NDC 0904-6803 Quetiapine · Quetiapine Fumarate 200 mg/1 · Major Pharmaceuticals
- NDC 0904-6801 Quetiapine · Quetiapine Fumarate 50 mg/1 · Major Pharmaceuticals
- NDC 0904-6804 Quetiapine · Quetiapine Fumarate 300 mg/1 · Major Pharmaceuticals