March 2018 FDA Recall Drug by United Pacific Co Ltd
D-0624-2018 - CGMP Deviations

This Class II drug recall was voluntarily initiated by United Pacific Co Ltd on March 29, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0624-2018

Reason for Recall
CGMP Deviations: the product was produced with substandard GMP manufacturing processes.
Initiated
03-29-2018
Reported
04-18-2018
Quantity
15,190 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79693
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.
United Pacific Co Ltd
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 US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-24-2019
Product Description About Product Description
Full technical description of the product.
Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC 6 924938 100226, NDC 53614-001-02

Batch or Lot Expiration Information

Lot# :14122921, Exp.12/30/20119, 15091512, Exp. 9/15/2020, 6032321, Exp. 3/23/2021, 17030921, Exp. 3/09/2022