FDA Drug recall D-0839-2020
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701
- FDA Drug
- Class II
- terminated
- Published 2020-02-19
On 2020-02-19 the FDA classified a Class II recall of Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701 by Akorn, citing subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0839-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-16 |
| Published | 2020-02-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akorn |
| Distribution | US |
Product
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.
Reason
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Identifiers
| code_info | Lot #: 364667, Exp 12/20/2019 |
|---|
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-0839-2020%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.