FDA Drug recall D-1609-2014
Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc
- FDA Drug
- Class III
- terminated
- Published 2014-10-01
On 2014-10-01 the FDA classified a Class III recall of Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc by Apotex, citing subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1609-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-04-18 |
| Published | 2014-10-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Apotex |
| Distribution | US |
Product
Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03
Reason
Subpotent Drug: Out of specification (OOS) results at the 9 month temperature point.
Identifiers
| code_info | Lot # KM4951; Exp. 04/15 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1609-2014%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.