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Class II: temporary or reversible health riskTerminated

Inopak INOFOAM Foaming E-2 Food Handling Wash with Recall

INOFOAM Foaming E-2 Food Handling Wash with

Inopak Ltd · Ringwood, NJ

Risk level
Class II
Reported by FDA
Jun 5, 2019
Recall ID
D-1314-2019
Check your lot numberHow we source this data

Summary

Inopak recalled INOFOAM Foaming E-2 Food Handling Wash with starting Apr 22, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1314-2019 on Jun 5, 2019. Reason: CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices. Status: Terminated.

Why it was recalled

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

Product description

INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML pouches per case (NDC 058575-110-80), 5064-FL1000, Inopak, LTD.

Lot numbers, UPCs & expiration codes

Batch #: 7304, 7180, 6707, 7065

Where it was sold

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-1314-2019
Classification
Class II
Status
Terminated
Recall initiated
Apr 22, 2019
FDA report date
Jun 5, 2019
Quantity
17,850 pounds per batch
Recall type
Voluntary: Firm initiated
Recalling firm
Inopak Ltd

Original FDA data

Every field from FDA enforcement report D-1314-2019, exactly as published.

Show all FDA fields
City
Ringwood
State
NJ
Status
Terminated
Country
United States
Event ID
82645
Address
24 Executive Pkwy
Code information
Batch #: 7304, 7180, 6707, 7065
Postal code
07456-1430
Report date
Jun 5, 2019
Product type
Drugs
Recall number
D-1314-2019
Classification
Class II
Recalling firm
Inopak Ltd
Product quantity
17,850 pounds per batch
Termination date
Aug 28, 2024
Reason for recall
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Voluntary / mandated
Voluntary: Firm initiated
Product description
INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML pouches per case (NDC 058575-110-80), 5064-FL1000, Inopak, LTD.
Distribution pattern
Nationwide in the USA
Recall initiation date
Apr 22, 2019
Initial firm notification
Letter
Center classification date
May 29, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1314-2019, published Jun 5, 2019. 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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