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Class II: temporary or reversible health riskTerminated

Soluciones Cosmeticas, SA de CV Bersih Hand Sanitizer Gel Recall

Bersih Hand Sanitizer Gel

Soluciones Cosmeticas, SA de CV · Ciudad De Mexico, N/A

Risk level
Class II
Reported by FDA
Sep 9, 2020
Recall ID
D-1560-2020
Check your lot numberHow we source this data

Summary

Soluciones Cosmeticas, SA de CV recalled Bersih Hand Sanitizer Gel starting Jul 14, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1560-2020 on Sep 9, 2020. Reason: cGMP Deviations. Status: Terminated.

Why it was recalled

cGMP Deviations

Product description

Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Distributed by RediBag USA 135 Fulton Ave New Hyde Park, NY 11040 UPC 8 16822 02666 7

Lot numbers, UPCs & expiration codes

All lots remaining within expiry.

Where it was sold

United States

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1560-2020
Classification
Class II
Status
Terminated
Recall initiated
Jul 14, 2020
FDA report date
Sep 9, 2020
Quantity
2,486,400 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Soluciones Cosmeticas, SA de CV

Original FDA data

Every field from FDA enforcement report D-1560-2020, exactly as published.

Show all FDA fields
City
Ciudad De Mexico
Status
Terminated
Country
Mexico
Event ID
86042
Address
Avenida Ano De Juarez 110
Address (line 2)
Otro Granjas San Antonio, Iztapalapa
Code information
All lots remaining within expiry.
Report date
Sep 9, 2020
Product type
Drugs
Recall number
D-1560-2020
Classification
Class II
Recalling firm
Soluciones Cosmeticas, SA de CV
Product quantity
2,486,400 bottles
Termination date
Feb 22, 2022
Reason for recall
cGMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Distributed by RediBag USA 135 Fulton Ave New Hyde Park, NY 11040 UPC 8 16822 02666 7
Distribution pattern
United States
Recall initiation date
Jul 14, 2020
Initial firm notification
Press Release
Center classification date
Sep 2, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1560-2020, published Sep 9, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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