DrugOct 25, 2023
Betaxolol Tablets, USP 10 mg recall — FDA D-0049-2024
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Class IFDA: TerminatedKVK-Tech, Inc.
Recall history in this database
Classification mix: Class II: 4, Class III: 3, Class I: 2.
DrugSep 1, 2021
Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle recall — FDA D-0772-2021
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Class IFDA: TerminatedKVK-Tech, Inc.
DrugJan 20, 2021
KVK-Tech Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets recall — FDA D-0224-2021
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Class IIIFDA: TerminatedKVK-Tech, Inc.
DrugNov 20, 2019
Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 recall — FDA D-0532-2020
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Class IIFDA: TerminatedKVK-Tech, Inc.
DrugAug 23, 2017
Phentermine HCL Capsules, USP 15 mg recall — FDA D-1083-2017
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
Class IIIFDA: TerminatedKVK-Tech, Inc.
DrugSep 2, 2015
KVK-Tech Phentermine Hydrochloride Capsules, USP, 15 mg recall — FDA D-1371-2015
Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Class IIIFDA: TerminatedKVK-Tech, Inc.
DrugJan 29, 2014
HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles recall — FDA D-1030-2014
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Class IIFDA: TerminatedKVK-Tech, Inc.
DrugJan 29, 2014
HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles recall — FDA D-1031-2014
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Class IIFDA: TerminatedKVK-Tech, Inc.
DrugJan 29, 2014
HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles recall — FDA D-1032-2014
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Class IIFDA: TerminatedKVK-Tech, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies KVK-Tech, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.