FDA Drug recall D-0001-2019
Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 00…
- FDA Drug
- Class II
- terminated
- Published 2018-10-10
On 2018-10-10 the FDA classified a Class II recall of Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 00… by Teva Pharmaceuticals Usa, citing failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0001-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-21 |
| Published | 2018-10-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with 13 on one side and plain on the other side.
Reason
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Identifiers
| ndc | 0093-5416-01 |
|---|---|
| ndc | 0093-5417-01 |
| ndc | 0093-5417-19 |
| ndc | 0093-5417-84 |
| ndc | 0093-5419-01 |
| ndc | 0093-5419-19 |
| ndc | 0093-5419-84 |
| ndc | 0093-5376-01 |
| ndc | 0093-5376-19 |
| ndc | 0093-5376-84 |
| ndc | 0093-5377-01 |
| ndc | 0093-5377-19 |
| ndc | 0093-5377-84 |
| code_info | Lot #: 34034024B, Exp 02/20 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0001-2019%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.