November 2019 FDA Recall Hydrocodone Bitartrate And Homatropine Methylbromide by Kvk-tech, Inc.
D-0532-2020 - Presence of Foreign Substance

This Class II drug recall was voluntarily initiated by Kvk-tech, Inc. on November 1, 2019 for the product Hydrocodone Bitartrate And Homatropine Methylbromide. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0532-2020

Reason for Recall
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Initiated
11-01-2019
Reported
11-20-2019
Quantity
1534 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84184
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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 within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-16-2020
Product Description About Product Description
Full technical description of the product.
Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd. by: KVK-Tech, Inc. Newtown PA 18940; NDC 10702-150-16

Batch or Lot Expiration Information

Lot# : 14375A, Exp. date 2019-DEC; 14398A, Exp. date 2020-JAN

Affected Packages Involved in this Recall

10702-150-16 Hydrocodone Bitartrate And Homatropine Methylbromide