FDA Drug recall D-0249-2019
Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Sta…
- FDA Drug
- Class III
- terminated
- Published 2018-10-24
On 2018-10-24 the FDA classified a Class III recall of Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Sta… by Amerigen Pharmaceuticals, citing failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0249-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-10-05 |
| Published | 2018-10-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amerigen Pharmaceuticals |
| Distribution | US |
Product
Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071.
Reason
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Identifiers
| code_info | Lot #: a) 17F058A, Exp 6/19; b) 17F058B, Exp 6/19 |
|---|
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-0249-2019%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.