July 2018 FDA Recall Drug by Medgyn Products, Inc.
D-0917-2018 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Medgyn Products, Inc. on July 3, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0917-2018

Reason for Recall
CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
Initiated
07-03-2018
Reported
07-18-2018
Quantity
2750 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80309
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.
Medgyn Products, 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
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA, Barbados, Cayman Islands, Chile, Cyprus, Ecuador, El Salvador, Guatemala, Hong Kong, Kuwait, Lebanon, Malaysia, Maldives, Mexico, Mongolia, Montenegro, Mozambique, Pakistan, Paraguay, Peru, Republic of Georgia, Serbia, South Africa, Tanzania, United Arab Emirates, Venezuela, and Vietnam.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-28-2020
Product Description About Product Description
Full technical description of the product.
Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: MedGyn Products, Inc., 100 W. Industrial Rd., Addison, IL 60101 USA; Manufactured By: BioDiagnostics Intl, 555 West Lambert Road Unit-C, Brea, CA 92821, NDC 42721-112-08.

Batch or Lot Expiration Information

Lot# s: all lots within expiry