FDA Drug recall D-0824-2018
Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01
- FDA Drug
- Class II
- terminated
- Published 2018-05-30
On 2018-05-30 the FDA classified a Class II recall of Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01 by Mylan Pharmaceuticals, citing CGMP Deviations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0824-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-24 |
| Published | 2018-05-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mylan Pharmaceuticals |
| Distribution | US |
Product
Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01
Reason
CGMP Deviations
Identifiers
| code_info | NDC # 0378-7025-01 Lot Numbers: 3083756, Exp. 3/31/19 3083757, Exp. 3/31/19 3083758, Exp. 3/31/19 3083759, Exp.…NDC # 0378-7025-01 Lot Numbers: 3083756, Exp. 3/31/19 3083757, Exp. 3/31/19 3083758, Exp. 3/31/19 3083759, Exp. 3/31/19 3083760, Exp. 3/31/19 3083761, Exp. 3/31/19 |
|---|
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 · 2026-08-05 · Mylan Pharmaceuticals - Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals…
FDA Drug · Class II · 2026-03-11 · Mylan Pharmaceuticals
All Mylan Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0824-2018%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.