Recalls / Class III
Class IIID-1417-2012
Product
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.
- Affected lot / 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
Why it was recalled
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-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
- 73,746 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-07-06
- FDA classified
- 2012-07-13
- Posted by FDA
- 2012-07-25
- Terminated
- 2013-12-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1417-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.