KVK Tech recalls
FDA enforcement reports naming KVK Tech, Inc. as the recalling firm.
- Recall reports
- 15
- Class I (serious)
- 2
- Most recent report
- May 28, 2025
- May 28, 2025Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, MfdDrug · KVK Tech, Inc.cGMP deviationsClass II
- May 28, 2025Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, MfdDrug · KVK Tech, Inc.cGMP deviationsClass II
- Oct 25, 2023Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech IncDrug · KVK-Tech, Inc.Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.Class I
- Sep 1, 2021Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, MfdDrug · KVK-Tech, Inc.Temperature abuse: the firm received customer complaints of unusual grittiness in the product.Class I
- May 26, 2021Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1Drug · KVK-Tech, Inc.Failed Impurities/Degradation SpecificationsClass III
- Jan 20, 2021Benzhydrocodone and Acetaminophen Tablets, CII, 6Drug · KVK-Tech, Inc.Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892AClass III
- Nov 20, 2019Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1Drug · KVK-Tech, Inc.Presence of Foreign Substance: Black particles were found in the lots during retain sample inspectionClass II
- Oct 23, 2019Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alco…Drug · KVK-Tech, Inc.Presence of Foreign Substance; Fiber particles.Class III
- Dec 26, 2018Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, MfdDrug · KVK-Tech, Inc.Labeling: Wrong bar codeClass II
- Aug 23, 2017Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01…Drug · KVK-Tech, Inc.Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.Class III
- Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KVK-TECH,…
- Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10…
- HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only
- HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only
- HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only
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