KVK-Tech, Inc.: HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-012-01, 500 count NDC: 10702-012-50, 1000 c

Is my product affected?

HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-012-01, 500 count NDC: 10702-012-50, 1000 count NDC: 10702-012-10.

• Brand HYDROXYZINE HYDROCHLORIDE

Check against the official notice below — it lists the full affected range.

What happened

KVK-Tech, Inc. is recalling HydrOXYzine HCI Tablets USP 50 mg in 100, 500, and 1000 count bottles nationwide, including Puerto Rico. The recall affects approximately 104,551 bottles distributed to wholesale distributors for sale to retail establishments. The product is being recalled because the Active Pharmaceutical Ingredient came from an unapproved source, which constitutes a Good Manufacturing Practices deviation.

The recall involves multiple lot numbers across different package sizes with expiration dates ranging from January 2014 through November 2015. Specific affected lot numbers include 10667, 10677, 10679, 10688, 10693, 10854, 10942, 10995, 10996, 11138, 11139, 11140, 11445, 10689, 10941, 10997, 10998, 10999, 11136, and 11137. The source does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.

Details from the source

Reason for recall: Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source. Distribution: Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments. Quantity: 104551 bottles Lot/code info: NDC 10702-012-01: lot # 10667, Jan-14; lot # 10677, exp. Jan-14; lot # 10679, exp. Jan-14; lot# 10688, exp. May-14; lot #10693, exp. Jul-14; lot #10854, Jul-14; lot # 10942, exp. Sep-14; lot #10995, exp.Oct-14; lot # 10996, Nov-14; lot #11138, exp. Feb-15; lot # 11139 Feb-15; lot # 11140, exp. Feb-15; lot # 11445, exp. Nov-15. NDC: 10702-012-10: lot # 10679, exp. Jan-14; lot # 10689, exp. Jun-14; lot # 10941, Sep-14; lot #10997; Nov-14; lot #10998, Nov-14; lot # 10999, Nov-14; lot #11445, exp. Nov-15. NDC: 10702-012-50: lot #10678, exp. Jan-14; lot #10689, exp. Jun-14; lot #10855, exp. Jul-14; lot # 10943, exp. Sep-14; lot # 11136, exp. Feb-15; lot #11137, exp. Feb-15; lot# 11445, exp. Nov-15.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-011-01, 500 count NDC: 10702-011-50, 1000 count NDC: 10702-011-10.2013-12-11
• Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, packaged in 5 Units x 20 mL per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.2013-12-12
• Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-47); b) 1 oz (22g) (NDC 11527-163-55) SHEFFIELD PHARMACEUTICALS, New London, CT 063202013-11-22
• 5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product code 2B0089, NDC 0338-0017-38.2013-11-21
• 0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) and b) 100 mL Single dose VIAFLEX plastic containers (Product code 2B1302, NDC 0338-0049-18) and (Product code 2B1309, NDC 0338-0049-38), Rx only, Baxter Healthcar2013-11-21

All FDA (Drug enforcement) recalls