January 2020 FDA Recall Drug by Shandex Personal Care Manufacturing Inc. (D-0822-2020 - Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturing).)

This Class II drug recall was voluntarily initiated by Shandex Personal Care Manufacturing Inc. on January 16, 2020 for the product Drug. The FDA reported the reason for recall as presence of foreign substance; metal contaminant visible in product (screen wire from manufacturing).. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0822-2020

Reason for Recall
Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturing).
Initiated
01-16-2020
Reported
02-05-2020
Quantity
20448 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84757
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.
Shandex Personal Care Manufacturing 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 U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-06-2020
Product Description About Product Description
Full technical description of the product.
Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 bar per carton, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, NDC: 0363-0137-11

Batch or Lot Expiration Information

Lot# : L 19173, Exp 06/20/2021