Drug 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
D-1001-2020
Product summary
- Event
- Event 85138
- Status
- Terminated
- Classification
- Class III
- Quantity
- 115 cartons
- Official record key
drug-enforcement:D-1001-2020
Official wording
Reason: Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Code information: Lot, expiry: Lot N00037, exp 05/2021
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling; Incorrect or Missing