HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01

FDA recall notice · announced April 9, 2014 · American Health Packaging

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

Notes

Distribution: Nationwide
Lot/code information: Lot 120407, Exp 01/14; Lot 121337 Exp 03/14; Lot 122054, Exp 05/14; Lot 122598, Exp 06/14; Lot 130125, Exp 12/14
Quantity: 14,665 blister packs
Status: Terminated
Products in this recall event:
- HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01 (D-1189-2014)
- HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01 (D-1188-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.