Acetic Acid Otic Solution — Class III drug recall D-302-2013
Terminated recall by Hi-Tech Pharmacal Co., Inc., reported 2013-05-08, distributed nationwide. Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month tes
| Recall number | D-302-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hi-Tech Pharmacal Co., Inc., Amityville, NY, United States |
| Recall initiated | 2013-03-11 |
| Classified | 2013-04-30 |
| Reported by FDA | 2013-05-08 |
| Terminated | 2016-05-13 |
| Distributed | Nationwide (US) |
| Quantity | 11,472 bottles |
| Reason classes | potency, specification failure |
| NDC | 50383-0889-15 |
| Lot numbers | 06/13, 610593 |
Product
Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1.
Reason for recall
Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.
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-302-2013. 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.