Hydrocortisone and Acetic Acid Otic Solution — Class II drug recall D-1011-2019
Terminated recall by Akorn Inc, reported 2019-03-27, distributed nationwide. Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 mont
| Recall number | D-1011-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn Inc, Lake Forest, IL, United States |
| Recall initiated | 2019-03-12 |
| Classified | 2019-03-20 |
| Reported by FDA | 2019-03-27 |
| Terminated | 2022-08-01 |
| Distributed | Nationwide (US) |
| Quantity | 15,322 |
| Reason classes | potency, specification failure |
| NDC | 50383-0901-10 |
| Lot numbers | 357647 |
| Expiration dates | 2019-04 |
Product
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701. NDC: 50383-901-10
Reason for recall
Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1011-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.