September 2024 FDA Recall Drug by Enviroserve Chemicals Inc.
D-0667-2024 - CGMP deviations

This Class II drug recall was voluntarily initiated by Enviroserve Chemicals Inc. on September 18, 2024 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was sent to one distributor in North Carolina. and the recall is currently ongoing.

Recall Number: D-0667-2024

Reason for Recall
CGMP deviations
Initiated
09-18-2024
Reported
10-02-2024
Quantity
120 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95390
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.
EnviroServe Chemicals 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.
Product was sent to one distributor in North Carolina.
Product Description About Product Description
Full technical description of the product.
EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1

Batch or Lot Expiration Information

Lot# : 042224-L1, Exp. Date 04/22/2025