Hydroxyzine Hydrochloride Oral Solution recall: Impurity Out of Spec
HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811…
Why was Hydroxyzine Hydrochloride Oral Solution recalled?
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811…
- Recalling firm
- Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
- Quantity
- 73,746 bottles
- Distribution
- Nationwide
- Recall date
- July 25, 2012
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)