FDA Drug recall D-0806-2021
Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr.…
- FDA Drug
- Class II
- terminated
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class II recall of Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr.… by The Harvard Drug Group, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0806-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-29 |
| Published | 2021-09-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | The Harvard Drug Group |
| Distribution | CO, FL, MO, OH |
Product
Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC 0904-6822-04
Reason
Failed Dissolution Specifications
Identifiers
| ndc | 0904-6822-04 |
|---|---|
| ndc | 0904-6822-07 |
| code_info | Lot, expiry: N00187, 05/2022; N00245, 06/2022; N00273, 07/2022; N00355, 11/2022 |
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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FDA Drug · Class II · 2025-10-29 · The Harvard Drug Group
All The Harvard Drug Group recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0806-2021%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.