Recalls / Class III
Class IIID-1411-2012
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.
- Affected lot / code info
- 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
Why it was recalled
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
Recalling firm
- Firm
- Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 120 Vintage Dr NE, Huntsville, Alabama 35811-8216
Distribution
- Quantity
- 54,431 bottles
- Distribution pattern
- Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2012-07-06
- FDA classified
- 2012-07-11
- Posted by FDA
- 2012-07-18
- Terminated
- 2013-02-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1411-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.