Hydrocortisone and Acetic Acid Otic Solution — Class III drug recall D-0295-2016
Terminated recall by Akorn, Inc., reported 2015-11-25, distributed nationwide. Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "
| Recall number | D-0295-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2015-08-21 |
| Classified | 2015-11-16 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2017-11-29 |
| Distributed | Nationwide (US) |
| Quantity | 13,896 bottles |
| Reason classes | labeling, packaging |
| NDC | 50383-0901-10 |
| Lot numbers | 346191 |
| Expiration dates | 2016-12 |
Product
Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10
Reason for recall
Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.
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-0295-2016. 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.