April 2021 FDA Recall Hydrocodone Bitartrate And Homatropine Methylbromide by Kvk-tech, Inc.
D-0386-2021 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Kvk-tech, Inc. on April 27, 2021 for the product Hydrocodone Bitartrate And Homatropine Methylbromide. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0386-2021

Reason for Recall
Failed Impurities/Degradation Specifications
Initiated
04-27-2021
Reported
05-26-2021
Quantity
17,096 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87810
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.
Distributed Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-05-2022
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Lot: 15684A, Exp 7/2021

Affected Packages Involved in this Recall

10702-055-03 Hydrocodone Bitartrate And Homatropine Methylbromide
10702-055-09 Hydrocodone Bitartrate And Homatropine Methylbromide
10702-055-01 Hydrocodone Bitartrate And Homatropine Methylbromide
10702-055-10 Hydrocodone Bitartrate And Homatropine Methylbromide