FDA Drug recall D-0344-2019
Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Sta…
- FDA Drug
- Class III
- terminated
- Published 2019-01-02
On 2019-01-02 the FDA classified a Class III recall of Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Sta… by Amerigen Pharmaceuticals, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0344-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-12-20 |
| Published | 2019-01-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amerigen Pharmaceuticals |
| Distribution | n/a |
Product
Temozolomide Capsules, 20 mg, packaged in a a) 5-count (NDC 43975-253-05) and b) 14 count (NDC 43975-253-14) bottles, Rx only, Mfd, by: Stason Pharmaceuticals, Inc., Irvine, CA, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ
Reason
Failed Dissolution Specifications
Identifiers
| code_info | a) Lot # 18B005 A and b) Lot # 18B005 B, exp 02/2020 |
|---|
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-0344-2019%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.