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Class II: temporary or reversible health riskTerminated

Spartan Chemical Antiseptic Hand Cleaner Recall

Antiseptic Hand Cleaner (Chloroxylenol, 1

Spartan Chemical Co Inc · Maumee, OH

Risk level
Class II
Reported by FDA
Apr 21, 2021
Recall ID
D-0361-2021
Check your lot numberHow we source this data

Summary

Spartan Chemical recalled Antiseptic Hand Cleaner starting Mar 29, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0361-2021 on Apr 21, 2021. Reason: CGMP Deviations. Status: Terminated.

Why it was recalled

CGMP Deviations

Product description

Antiseptic Hand Cleaner (Chloroxylenol, 1.0%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA.UPC 7 53727 26257 1 NDC: 64009-336-85

Lot numbers, UPCs & expiration codes

Lot, expiry: Lot 538885, exp 1/25/2023

Where it was sold

Nationwide USA and Puerto Rico; Mexico

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-0361-2021
Classification
Class II
Status
Terminated
Recall initiated
Mar 29, 2021
FDA report date
Apr 21, 2021
Quantity
400 containers
Recall type
Voluntary: Firm initiated
Recalling firm
Spartan Chemical Co Inc

Original FDA data

Every field from FDA enforcement report D-0361-2021, exactly as published.

Show all FDA fields
City
Maumee
State
OH
Status
Terminated
Country
United States
Event ID
87633
Address
1110 Spartan Dr
Code information
Lot, expiry: Lot 538885, exp 1/25/2023
Postal code
43537-1725
Report date
Apr 21, 2021
Product type
Drugs
Recall number
D-0361-2021
Classification
Class II
Recalling firm
Spartan Chemical Co Inc
Product quantity
400 containers
Termination date
Oct 16, 2023
Reason for recall
CGMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
Product description
Antiseptic Hand Cleaner (Chloroxylenol, 1.0%), Net Contents: 1 US Gallon/ 3.79 Liters per gallon container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA.UPC 7 53727 26257 1 NDC: 64009-336-85
Distribution pattern
Nationwide USA and Puerto Rico; Mexico
Recall initiation date
Mar 29, 2021
Initial firm notification
Letter
Center classification date
Apr 30, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0361-2021, published Apr 21, 2021. 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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