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Class I: serious health riskTerminated

Real Clean Distribuciones SA de CV Born Basic Recall

BORN BASIC

Real Clean Distribuciones SA de CV · Tlalnepantla De Baz, N/A

Risk level
Class I
Reported by FDA
Sep 23, 2020
Recall ID
D-1583-2020
Check your lot numberHow we source this data

Summary

Real Clean Distribuciones SA de CV recalled Born Basic starting Jul 23, 2020. The FDA classified it as Class I (serious health risk) and published enforcement report D-1583-2020 on Sep 23, 2020. Reason: Chemical Contamination: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol. Status: Terminated.

Why it was recalled

Chemical Contamination: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Product description

BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3, Made in Mexico; Distributed by Scent Theory Products, LLC, New York, NY 10018.

Lot numbers, UPCs & expiration codes

Lots: 1033420, 1133420, 1233420, 2233420, 2333420, 2433420, 2533420

Where it was sold

Distributed Nationwide in the USA

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-1583-2020
Classification
Class I
Status
Terminated
Recall initiated
Jul 23, 2020
FDA report date
Sep 23, 2020
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
Real Clean Distribuciones SA de CV

Original FDA data

Every field from FDA enforcement report D-1583-2020, exactly as published.

Show all FDA fields
City
Tlalnepantla De Baz
Status
Terminated
Country
Mexico
Event ID
86105
Address
Recursos Petroleros
Address (line 2)
Fracc Industrial La Loma 3; Tlalnepantla De Baz
Code information
Lots: 1033420, 1133420, 1233420, 2233420, 2333420, 2433420, 2533420
Report date
Sep 23, 2020
Product type
Drugs
Recall number
D-1583-2020
Classification
Class I
Recalling firm
Real Clean Distribuciones SA de CV
Termination date
May 27, 2022
Reason for recall
Chemical Contamination: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Voluntary / mandated
Voluntary: Firm initiated
Product description
BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3, Made in Mexico; Distributed by Scent Theory Products, LLC, New York, NY 10018.
Distribution pattern
Distributed Nationwide in the USA
Recall initiation date
Jul 23, 2020
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
Sep 11, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1583-2020, published Sep 23, 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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