Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

HYDROCORTISONE and ACETIC ACID OTIC SOLUTION Recalled by Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals Due to Impurities/Degradation Products: Out of specificiation results for impurities...

Date: July 6, 2012
Company: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals directly.

Affected Products

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.

Quantity: 54,431 bottles

Why Was This Recalled?

Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report