FDA Drug recall D-1411-2012
HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
- FDA Drug
- Class III
- terminated
- Published 2012-07-18
On 2012-07-18 the FDA classified a Class III recall of HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 by Vintage Pharmaceuticals, citing impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1411-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-07-06 |
| Published | 2012-07-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Vintage Pharmaceuticals |
| Distribution | US |
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
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
Identifiers
| upc | 306037039397 |
|---|---|
| code_info | Lot #: L072B11A, Exp 8/12; L102C11A, L103C11A, Exp 10/12; L046D11A, L082F11A, L089F11A, Exp 11/12; L148J11A, L149J11A,…Lot #: L072B11A, Exp 8/12; L102C11A, L103C11A, Exp 10/12; L046D11A, L082F11A, L089F11A, Exp 11/12; L148J11A, L149J11A, L150J11A, Exp 03/13; and L151J11A, Exp 04/13 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1411-2012%22
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