August 2017 FDA Recall Drug by Lucky Mart Inc.
D-0031-2018 - Incorrect Product Formulation

This Class I drug recall was voluntarily initiated by Lucky Mart Inc. on August 29, 2017 for the product Drug. The FDA reported the reason for recall as incorrect product formulation. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0031-2018

Reason for Recall
Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone.
Initiated
08-29-2017
Reported
11-01-2017
Quantity
13,800 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78051
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lucky Mart 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 in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-30-2018
Product Description About Product Description
Full technical description of the product.
PIYANPING Anti-Itch (hydrocortisone) Lotion, 1%, Net Wt. 0.67 oz (20g) tube, Manufactured By: Jimin Pharmaceutial Co., LTD., Distributor: Lucky Mart, El Monte, CA 91733, NDC 68085-8012-4.

Batch or Lot Expiration Information

Lot# : C16001, C16002, Exp 12/18