FDA Drug recall D-1001-2020
Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur…
- FDA Drug
- Class III
- terminated
- Published 2020-03-18
On 2020-03-18 the FDA classified a Class III recall of Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur… by The Harvard Drug Group, citing labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1001-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-02-27 |
| Published | 2020-03-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | The Harvard Drug Group |
| Distribution | US |
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
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Identifiers
| ndc | 0904-6801-61 |
|---|---|
| ndc | 0904-6802-61 |
| ndc | 0904-6803-61 |
| ndc | 0904-6804-61 |
| ndc | 0904-6805-61 |
| code_info | Lot, expiry: Lot N00037, exp 05/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All The Harvard Drug Group recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1001-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.