FDAFDA · Food and drugs·Recall number D-1411-2012
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.
Published July 18, 2012 · Recall initiated: July 6, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
- Distributor
- Nationwide and Puerto Rico.
- Lot
- 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
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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