FDA Drug recall D-0528-2021
Epinephrine Injection, USP Auto-Injectors in all strengths, packs and styles Manufactured for Mylan Specialty L.P., Morgantown, WV , NDC: 9…
- FDA Drug
- Class II
- terminated
- Published 2021-06-02
On 2021-06-02 the FDA classified a Class II recall of Epinephrine Injection, USP Auto-Injectors in all strengths, packs and styles Manufactured for Mylan Specialty L.P., Morgantown, WV , NDC: 9… by Cardinal Health, citing CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0528-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-15 |
| Published | 2021-06-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cardinal Health |
| Distribution | FL, GA, SC |
Product
Epinephrine Injection, USP Auto-Injectors in all strengths, packs and styles Manufactured for Mylan Specialty L.P., Morgantown, WV , NDC: 9502-500-01, 49502-500-02, 49502-500-92, 49502-501-01
Reason
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Identifiers
| ndc | 49502-500-01 |
|---|---|
| ndc | 49502-500-02 |
| ndc | 49502-500-92 |
| ndc | 49502-501-01 |
| ndc | 49502-501-02 |
| ndc | 49502-501-92 |
| code_info | 0FM544 |
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-0528-2021%22
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