Status
Terminated
Drug Enforcement D-394-2014
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Classification
Class III
Report Date
January 8, 2014
Termination Date
October 7, 2014
Product Information
- 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).
- Product quantity
- 438,055 bottles
- Reason for recall
- Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Qualitest Pharmaceuticals
- Address
-
120 Vintage Dr NE
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-394-2014
- Event ID
- 67102
- Recall initiation date
- December 16, 2013
- Center classification date
- December 31, 2013
- Code info
- 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.
- More code info
- —