July 2019 FDA Recall Drug by Dercher Enterprises, Inc., Dba Gordon Laboratories
D-1528-2019 - Microbial Contamination of Non-Sterile Products and Superpotent Drug

This Class II drug recall was voluntarily initiated by Dercher Enterprises, Inc., Dba Gordon Laboratories on July 19, 2019 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products and superpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1528-2019

Reason for Recall
Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content.
Initiated
07-19-2019
Reported
07-31-2019
Quantity
277 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83399
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.
Dercher Enterprises, Inc., DBA Gordon Laboratories
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.
08-14-2023
Product Description About Product Description
Full technical description of the product.
MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.

Batch or Lot Expiration Information

Batch# : 579634, 579635, Exp 5/2020