FDA Drug recall D-1189-2014
HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01
- FDA Drug
- Class II
- terminated
- Published 2014-04-09
On 2014-04-09 the FDA classified a Class II recall of HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01 by American Health Packaging, citing good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1189-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-31 |
| Published | 2014-04-09 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | American Health Packaging |
| Distribution | US |
Product
HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01
Reason
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Identifiers
| code_info | Lot 120757, Exp. 02/14; Lot 121104, Exp 03/14; Lot 122055, Exp 05/14; Lot 123038, Exp 07/14; Lot 125115, Exp 11/14 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1189-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.