HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION — Class III drug recall D-1417-2012
Terminated recall by Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, reported 2012-07-25, distributed nationwide. Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-mon
| Recall number | D-1417-2012 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL, United States |
| Recall initiated | 2012-07-06 |
| Classified | 2012-07-13 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2013-12-09 |
| Distributed | Nationwide (US) |
| Quantity | 73,746 bottles |
| Reason classes | specification failure |
| NDC | 00603-1310-58 |
| Lot numbers | 01/14, 05/13, 06/13, 10/13, 12/13, L030F11A, L054F11A, L079J10A, L085K11A, L086K11A, L087G10A, L087K11A, L088K11A, L094L10A, L095E10A, L100L10B |
Product
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.
Reason for recall
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
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-1417-2012. 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.