Why it was recalled
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Product description
Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL).
Lot numbers, UPCs & expiration codes
Lot Numbers: NDC 0603-9063-54 (120 mL): L081K12A, exp. 4/14; L082K12A, exp. 4/14; L062M12A, exp. 6/14; L063M12A, exp. 6/14; L064M12A, exp. 6/14; L054A13A, exp. 7/14; L055A13A, exp. 7/14; L057A13A, exp. 7/14; L058A13A, exp. 7/14; L075B13A, exp. 8/14; L076B13A, exp 8/14; L003C13A, exp. 8/14; L004C13A, exp. 8/14; and L005C13A, exp. 8/14 NDC 0603-9063-58 (480 mL): L081K12B, exp. 4/14; L082K12B, exp. 4/14; L059A13A, exp. 7/14; L114E13A, exp. 10/14; L026G13A, exp. 12/14; and L081J13A, exp. 3/15.
Where it was sold
Nationwide and Puerto Rico
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-394-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 16, 2013
- FDA report date
- Jan 8, 2014
- Quantity
- 438,055 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Qualitest Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-394-2014, exactly as published.
Show all FDA fields
- City
- Huntsville
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 67102
- Address
- 120 Vintage Dr NE
- Code information
- Lot Numbers: NDC 0603-9063-54 (120 mL): L081K12A, exp. 4/14; L082K12A, exp. 4/14; L062M12A, exp. 6/14; L063M12A, exp. 6/14; L064M12A, exp. 6/14; L054A13A, exp. 7/14; L055A13A, exp. 7/14; L057A13A, exp. 7/14; L058A13A, exp. 7/14; L075B13A, exp. 8/14; L076B13A, exp 8/14; L003C13A, exp. 8/14; L004C13A, exp. 8/14; and L005C13A, exp. 8/14 NDC 0603-9063-58 (480 mL): L081K12B, exp. 4/14; L082K12B, exp. 4/14; L059A13A, exp. 7/14; L114E13A, exp. 10/14; L026G13A, exp. 12/14; and L081J13A, exp. 3/15.
- Postal code
- 35811-8216
- Report date
- Jan 8, 2014
- Product type
- Drugs
- Recall number
- D-394-2014
- Classification
- Class III
- Recalling firm
- Qualitest Pharmaceuticals
- Product quantity
- 438,055 bottles
- Termination date
- Oct 7, 2014
- Reason for recall
- Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL).
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Dec 16, 2013
- Initial firm notification
- Letter
- Center classification date
- Dec 31, 2013