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KVK-Tech, Inc.

Complete recall history across all FDA and CPSC categories — 13 total recalls

KVK-Tech, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (13)

FDA drug safety enforcement actions by KVK-Tech, Inc.

Date Product Reason Class
Sep 20, 2023 Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech In... Presence of Foreign Tablets/Capsules: There is a potential presence of oxycod... Class I
Jul 2, 2021 Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By... Temperature abuse: the firm received customer complaints of unusual grittines... Class I
Apr 27, 2021 Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 ... Failed Impurities/Degradation Specifications Class III
Dec 18, 2020 Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, R... Failed Impurities/Degradation Specifications; out of specification results ob... Class III
Nov 1, 2019 Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 m... Presence of Foreign Substance: Black particles were found in the lots during ... Class II
Oct 4, 2019 Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar... Presence of Foreign Substance; Fiber particles. Class III
Dec 11, 2018 Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: K... Labeling: Wrong bar code Class II
Aug 3, 2017 Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10... Failed Impurities/Degradation Specifications: out-of-specification results ob... Class III
May 5, 2016 Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by:... Discoloration: presence of scuffing marks on tablets. Class III
Jul 14, 2015 Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bott... Failed Impurities/Degradation Specifications: out-of-specification results fo... Class III
Dec 11, 2013 HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only.... Good Manufacturing Practices Deviations: The product has an Active Pharmaceut... Class II
Dec 11, 2013 HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only.... Good Manufacturing Practices Deviations: The product has an Active Pharmaceut... Class II
Dec 11, 2013 HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TEC... Good Manufacturing Practices Deviations: The product has an Active Pharmaceut... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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