November 2024 FDA Recall Drug by Generitech Corporation
D-0111-2025 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Generitech Corporation on November 22, 2024 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in CA and the recall is currently ongoing.

Recall Number: D-0111-2025

Reason for Recall
CGMP Deviations: Inconsistency in the water systems.
Initiated
11-22-2024
Reported
12-11-2024
Quantity
77.5lbs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95819
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Generitech Corporation
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA
Product Description About Product Description
Full technical description of the product.
10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature + Science, 1 fl. oz., 30 mL Bottle, For Professional Use Only, Only YourRx Inc., Chatsworth, CA 91311, Made in USA, Onlyyourrx.com.

Batch or Lot Expiration Information

Lot# : 2400017, Exp: 4/30/2026