Reported Jul 25, 2012 · Terminated
HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: QUALITEST…
Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals · 120 Vintage Dr NE · Huntsville, AL · 35811-8216
Is this the product you have?
- HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg
- for
QUALITEST PHARMACEUTICALSHUNTSVILLEAL 35811NDC 0603-1310-58UPC 3 0603-1310-58 4
- Lot codes and dates
Lot #s: L030F11AL054F11AExp 05/13L095E10AExp 06/13L079J10AL085K11AL086K11AL087G10AL087K11AL088K11AExp 10/13L094L10AExp 12/13and L100L10BExp 01/14
- Amount recalled
- 73,746 bottles
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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