Multi-event July 2017 FDA Recall Drug by Hardcore Formulations

This Multi-event Class I drug recall was voluntarily initiated by Hardcore Formulations on July 5, 2017 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1084-2017 TERMINATED D-1085-2017 TERMINATED

Recall Number: D-1084-2017

Reason for Recall
Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
Initiated
07-05-2017
Reported
08-23-2017
Quantity
1490 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77660
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.
HARDCORE FORMULATIONS
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-05-2020
Product Description About Product Description
Full technical description of the product.
ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcore Formulations UPC: 7 48252 68763 0

Batch or Lot Expiration Information

Lot# All lots remaining within expiry.

Recall Number: D-1085-2017

Reason for Recall
Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.
Initiated
07-05-2017
Reported
08-23-2017
Quantity
1440 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77660
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.
HARDCORE FORMULATIONS
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-05-2020
Product Description About Product Description
Full technical description of the product.
D-ZINE Rapid Size and Strength capsules, 10mgs, 90 count bottle, Hardcore Formulations, UPC: 7 48252 86193 1

Batch or Lot Expiration Information

Lot# All lots remaining within expiry.