KVK-Tech, Inc.: Drug Recall

Recall #D-0386-2021 · 04/27/2021

Class III: Low Risk

Recall Details

Recall Number: D-0386-2021
Classification: Class III
Product Type: Drug
Recalling Firm: KVK-Tech, Inc.
Status: Terminated
Date Initiated: 04/27/2021
Location: Newtown, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 17,096 bottles

Reason for Recall

Failed Impurities/Degradation Specifications

Product Description

Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech, Inc., Newtown, PA, 18940 NDC 10702-055-03

Distribution Pattern

Distributed Nationwide in the USA

Other Recalls by KVK-Tech, Inc.

Class II: Risk 05/09/2025

cGMP deviations
Class II: Risk 05/09/2025

cGMP deviations
Class I: Dangerous 09/20/2023

Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Class I: Dangerous 07/02/2021

Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Class III: Low Risk 12/18/2020

Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A

View all recalls by KVK-Tech, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.