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Class II: temporary or reversible health riskTerminated

Alpha Aromatics Foaming Hand Sanitizer Recall

FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3

Alpha Aromatics · Pittsburgh, PA

Risk level
Class II
Reported by FDA
May 31, 2023
Recall ID
D-0760-2023
Check your lot numberHow we source this data

Summary

Alpha Aromatics recalled Foaming Hand Sanitizer starting May 16, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0760-2023 on May 31, 2023. Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. Status: Terminated.

Why it was recalled

CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

Product description

FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters bottle, 290 Alpha Drive RIDC industrial Park, Pittsburgh, PA 15238,

Lot numbers, UPCs & expiration codes

Lot: 2020-013211 and 2020-013629, No EXP date on label.

Where it was sold

Product was distributed to one account in NC.

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-0760-2023
Classification
Class II
Status
Terminated
Recall initiated
May 16, 2023
FDA report date
May 31, 2023
Quantity
544 1 gallon bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Alpha Aromatics

Original FDA data

Every field from FDA enforcement report D-0760-2023, exactly as published.

Show all FDA fields
City
Pittsburgh
State
PA
Status
Terminated
Country
United States
Event ID
92347
Address
294 Alpha Dr
Code information
Lot: 2020-013211 and 2020-013629, No EXP date on label.
Postal code
15238-2906
Report date
May 31, 2023
Product type
Drugs
Recall number
D-0760-2023
Classification
Class II
Recalling firm
Alpha Aromatics
Product quantity
544 1 gallon bottles
Termination date
Jul 1, 2024
Reason for recall
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Voluntary / mandated
Voluntary: Firm initiated
Product description
FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters bottle, 290 Alpha Drive RIDC industrial Park, Pittsburgh, PA 15238,
Distribution pattern
Product was distributed to one account in NC.
Recall initiation date
May 16, 2023
Initial firm notification
E-Mail
Center classification date
May 22, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0760-2023, published May 31, 2023. 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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