Status
Terminated
Drug Enforcement D-1411-2012
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
Classification
Class III
Report Date
July 18, 2012
Termination Date
February 1, 2013
Product Information
- Product description
- 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.
- Product quantity
- 54,431 bottles
- Reason for recall
- Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico.
Location & Firm
- Recalling firm
- Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
- Address
-
120 Vintage Dr NE
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1411-2012
- Event ID
- 62496
- Recall initiation date
- July 6, 2012
- Center classification date
- July 11, 2012
- 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
- More code info
- —