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.
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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1417-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 6, 2012
- FDA report date
- Jul 25, 2012
- Quantity
- 73,746 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-1417-2012, exactly as published.
Show all FDA fields
- City
- Huntsville
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 62495
- Address
- 120 Vintage Dr NE
- Code information
- 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
- Postal code
- 35811-8216
- Report date
- Jul 25, 2012
- Product type
- Drugs
- Recall number
- D-1417-2012
- Classification
- Class III
- Recalling firm
- Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
- Product quantity
- 73,746 bottles
- Termination date
- Dec 9, 2013
- Reason for recall
- Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 6, 2012
- Initial firm notification
- Letter
- Center classification date
- Jul 13, 2012