March 2018 FDA Recall Drug by Marcas Usa Llc
D-0628-2018 - Microbial Contamination of Non-Sterile Products

This Class II drug recall was voluntarily initiated by Marcas Usa Llc on March 30, 2018 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed in TX and the recall is currently terminated.

Recall Number: D-0628-2018

Reason for Recall
Microbial Contamination of Non-Sterile Products
Initiated
03-30-2018
Reported
04-25-2018
Quantity
69,238 60 oz. tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79689
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.
Marcas Usa Llc
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-15-2019
Product Description About Product Description
Full technical description of the product.
PASTA DE LASSAR ANDROMACO Skin Protection, 25% zinc oxide Topical cream, 60 gram tube, UPC #851357003004, NDC #75940-111-60

Batch or Lot Expiration Information

Lot# Lot Number(s): 15PL041, Exp. 04/18 15PL040, Exp. 04/18 15PL039, Exp. 05/18 17LP117, Exp. 10/20