Multi-event June 2018 FDA Recall Drug by Qualgen, Llc

This Multi-event Class III drug recall was voluntarily initiated by Qualgen, Llc on June 8, 2018 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0893-2018 TERMINATED D-0892-2018 TERMINATED

Recall Number: D-0893-2018

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date.
Initiated
06-08-2018
Reported
07-11-2018
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80203
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Qualgen, 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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01

Batch or Lot Expiration Information

Lot# D001 EXP: 01/02/2018 CPD: 01/02/2019

Recall Number: D-0892-2018

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date.
Initiated
06-08-2018
Reported
07-11-2018
Quantity
2,940 pellets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80203
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Qualgen, 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.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01

Batch or Lot Expiration Information

Lot# C211 Exp. date 10/03/2018; C257 Exp. date 12/14/2018 and
Lot# D001 exp. date 01/02/19