Cetirizine Hydrochloride Syrup — Class III drug recall D-394-2014
Terminated recall by Qualitest Pharmaceuticals, reported 2014-01-08, distributed nationwide. Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone
| Recall number | D-394-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qualitest Pharmaceuticals, Huntsville, AL, United States |
| Recall initiated | 2013-12-16 |
| Classified | 2013-12-31 |
| Reported by FDA | 2014-01-08 |
| Terminated | 2014-10-07 |
| Distributed | Nationwide (US) |
| Quantity | 438,055 bottles |
| Reason classes | specification failure |
| NDC | 00603-9063-54, 00603-9063-58 |
| Lot numbers | 0603-9063-54, 0603-9063-58, 10/14, 12/14, 3/15, 4/14, 6/14, 7/14, 8/14, L003C13A, L004C13A, L005C13A, L026G13A, L054A13A, L055A13A, L057A13A, L058A13A, L059A13A, L062M12A, L063M12A, L064M12A, L075B13A, L076B13A, L081J13A, L081K12A, L081K12B, L082K12A, L082K12B, L114E13A |
Product
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).
Reason for recall
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-394-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.