KVK-Tech, Inc.

FDA Regulatory Profile

Summary

Total Recalls
13 (2 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0049-2024Class IBetaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, September 20, 2023
D-0772-2021Class IAtovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., NewtoJuly 2, 2021
D-0386-2021Class IIIHydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, RxApril 27, 2021
D-0224-2021Class IIIBenzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured foDecember 18, 2020
D-0532-2020Class IIHydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottNovember 1, 2019
D-0142-2020Class IIIMethylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx October 4, 2019
D-0340-2019Class IIOxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown,December 11, 2018
D-1083-2017Class IIIPhentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 100August 3, 2017
D-1057-2016Class IIIBenzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KVK-TECH, INC., NewtowMay 5, 2016
D-1371-2015Class IIIPhentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; July 14, 2015
D-1032-2014Class IIHydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC,December 11, 2013
D-1031-2014Class IIHydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INCDecember 11, 2013
D-1030-2014Class IIHydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 189December 11, 2013