December 2020 FDA Recall Drug by Kvk-tech, Inc.
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

This Class III drug recall was voluntarily initiated by Kvk-tech, Inc. on December 18, 2020 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications; out of specification results obtained for n-oxide impurity during the 12-month long term stability testing for batch# 15892a. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0224-2021

Reason for Recall
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Initiated
12-18-2020
Reported
01-20-2021
Quantity
528 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87020
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
KVK-Tech, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-19-2021
Product Description About Product Description
Full technical description of the product.
Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 USA, NDC 10702-344-01

Batch or Lot Expiration Information

Batch# 15892A, Exp, 2021-FEB