FDA Recall D-0691-2021

Ardil Comercial S.R.L.

Class I — life-threatening Ongoing 1787 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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

Lot / code: Batch Number # 079932-4611-05-J, exp. date May 2022

Quantity: 1,260 bottles

Reason for recall

Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.

Recall record

Recall number: D-0691-2021
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Product was distributed to one client in NYC who further distributed the product.
Recall initiated: 2021-06-22
Classified by FDA Center: 2021-07-20
FDA published: 2021-07-21
Recalling firm: Ardil Comercial S.R.L.

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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