Status
Terminated
Drug Enforcement D-1417-2012
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
Classification
Class III
Report Date
July 25, 2012
Termination Date
December 9, 2013
Product Information
- Product description
- HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-1310-58, UPC 3 0603-1310-58 4.
- Product quantity
- 73,746 bottles
- Reason for recall
- Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
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-1417-2012
- Event ID
- 62495
- Recall initiation date
- July 6, 2012
- Center classification date
- July 13, 2012
- Code info
- Lot #s: L030F11A, L054F11A, Exp 05/13; L095E10A, Exp 06/13; L079J10A, L085K11A, L086K11A, L087G10A, L087K11A, L088K11A, Exp 10/13; L094L10A, Exp 12/13; and L100L10B, Exp 01/14
- More code info
- —