HYDROCORTISONE and ACETIC ACID OTIC SOLUTION — Class III drug recall D-1411-2012
Terminated recall by Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, reported 2012-07-18, distributed nationwide. Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature
| Recall number | D-1411-2012 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL, United States |
| Recall initiated | 2012-07-06 |
| Classified | 2012-07-11 |
| Reported by FDA | 2012-07-18 |
| Terminated | 2013-02-01 |
| Distributed | Nationwide (US) |
| Quantity | 54,431 bottles |
| Reason classes | specification failure |
| NDC | 00603-7039-39 |
| Lot numbers | 03/13, 04/13, 10/12, 11/12, 8/12, L046D11A, L072B11A, L082F11A, L089F11A, L102C11A, L103C11A, L148J11A, L149J11A, L150J11A, L151J11A |
Product
HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7.
Reason for recall
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
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-1411-2012. 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.