June 2021 FDA Recall Drug by Ardil Comercial S.r.l.
D-0691-2021 - Labeling Not Elsewhere Classified

This Class I drug recall was voluntarily initiated by Ardil Comercial S.r.l. on June 22, 2021 for the product Drug. The FDA reported the reason for recall as labeling not elsewhere classified. The product was distributed in Product was distributed to one client in NYC who further distributed the product. and the recall is currently ongoing.

Recall Number: D-0691-2021

Reason for Recall
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Initiated
06-22-2021
Reported
07-21-2021
Quantity
1,260 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88190
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ardil Comercial S.R.L.
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.
Product was distributed to one client in NYC who further distributed the product.
Product Description About Product Description
Full technical description of the product.
Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles, Manufactured in Dominican Republic: by Ardil Comercial S.R.L., Santo Domingo, Dominican Republic UPC 7 487040 301587

Batch or Lot Expiration Information

Batch# Batch Number # 079932-4611-05-J, exp. date May 2022