August 2019 FDA Recall Drug by Plastikon Healthcare Llc
D-1879-2019 - Microbial Contamination of Non-Sterile Products

This Class I drug recall was voluntarily initiated by Plastikon Healthcare Llc on August 30, 2019 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1879-2019

Reason for Recall
Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.
Initiated
08-30-2019
Reported
09-18-2019
Quantity
1,433 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83693
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.
Plastikon Healthcare 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
One distributor who further distributed Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-04-2020
Product Description About Product Description
Full technical description of the product.
Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use Only, packaged in 100-count cartons of 10 trays x 10 unit dose cups, Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.

Batch or Lot Expiration Information

Lot# Lots: 19027D, 19027E, Exp 07/21