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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

Inopak Ltd: Various Hand Sanitizers and Antibacterial Soaps Recalled for Quality Standards

Agency Publication Date: May 29, 2019
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Summary

Inopak Ltd is recalling approximately 178,500 units of various hand sanitizers and antibacterial soaps because they were not manufactured according to required Current Good Manufacturing Practices (CGMP). These products, sold nationwide under brands like InoFoam, DermaGel, Aquacil, and Sani-Guard-SF, include various formulations like foaming washes, waterless gels, and antiseptic soaps in sizes ranging from 2-ounce bottles to 1-gallon containers. Consumers should identify if they have any of the hundreds of affected batch numbers to avoid using potentially substandard hygiene products.

Risk

Failure to follow Good Manufacturing Practices means the safety, quality, and purity of these soaps and sanitizers cannot be guaranteed. This poses a risk that the products may not effectively kill germs or could contain unknown impurities, though no specific injuries or illnesses have been reported.

What You Should Do

  1. Check your product packaging for the brand names InoFoam, DermaGel, Aquacil, SaniTyze, Sani-Guard-SF, InoDerm, Style, or Unison to determine if you have a recalled item.
  2. Verify the batch or lot number on your product against the extensive list of affected codes, which includes numbers such as 6657, 6736, 7069, 7074, 7304, 6802, 6656, 6668, 6660, and 6827, among many others.
  3. Immediately stop using any of the affected hand sanitizers or antibacterial soaps.
  4. Contact your healthcare provider or pharmacist for guidance if you have any health concerns related to using these products.
  5. Return any unused product to the place of purchase for a full refund or contact Inopak Ltd at their New Jersey headquarters for further instructions.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Return affected products to the place of purchase for a full refund or contact the manufacturer if purchased directly.

Affected Products

Product: ANTIBACTERIAL Foaming Hand Wash With Moisturizers (18 oz, 1 gal, 1000 mL)
Model:
5063-432-02
5063-420-03
5063-OS1000
5063-FL1000
Lot Numbers (84):
6657
6666
6671
6679
6687
6695
6702
6718
6730
6744
6754
6760
6772
6773
6784
6793
6804
6812
6819
6838
6846
6856
6862
6877
6890
6896
6902
6910
6919
6938
6944
6953
6971
6985
6990
6998
7005
7012
7018
7028
7033
7039
7043
7053
7060
7068
7080
7092
7101
7110
Product: AQUACIL instant foaming hand sanitizer (18 oz, 1000 mL)
Model:
BIO-5075-432-02
BIO575-OS1000
Lot Numbers:
6736
6826
Product: DermaGel / SaniTyze Instant Waterless Hand Sanitizer (2 oz, 4 oz, 8 oz, 18 oz, 800 mL, 1000 mL, 1 gal)
Model:
5025-L1000
5025-480-02
5025-430-02
5025-440-03
5025-450-03
5025-404-NB
5025-4202-02
NDC 58575-340
Lot Numbers (117):
7069
6648
6649
6652
6654
6667
6669
6675
6677
6684
6686
6692
6694
6703
6704
6710
6717
6719
6726
6727
6731
6733
6739
6743
6748
6751
6752
6759
6763
6767
6769
6771
6775
6776
6780
6782
6787
6788
6801
6805
6808
6811
6814
6815
6821
6824
6825
6830
6831
6836
Product: INODERM Antiseptic Hand Soap (E-2) (800 mL)
Model:
5014-404-NB
NDC 058575-110
NDC 058575-110-80
Lot Numbers:
7074
Product: INOFOAM Foaming E-2 Food Handling Wash (1000 mL)
Model:
5064-FL1000
NDC 058575-110-11
NDC 058575-110-80
Lot Numbers:
7304
7180
6707
7065
Product: DERMA System CARE SaniClenz / MEDI-WASH CHG Anti-Microbial Hand Wash (1000 mL, 1 gal)
Model:
JSCG
Lot Numbers:
6802
6803
6909
6655
Product: Mild Health Care Antibacterial Hand Soap (800 mL, 1000 mL, 2000 mL, 1 gal)
Model:
5013-L1000
5013-XL2000
5013-404
5013-420-02
Lot Numbers:
6656
6959
7008
Product: Sani-Guard-SF Waterless Foam Hand Sanitizer (1000 mL)
Model:
5068-FL1000
5068-OS1000
Lot Numbers:
6668
6721
Product: STYLE / Choice Antibacterial Hand Soap (500 mL, 800 mL, 1000 mL, 8 oz, 18 oz)
Model:
5031-404-LN
5031-L1000
5031-404
5031-403-1B
5031-404-KC
5031-404-500-6
5031-404-500
5031-440-03
5031-430-02
5031-404UV-CH
Lot Numbers (109):
6660
6664
6676
6682
6685
6698
6701
6725
6732
6742
6744
6746
6756
6762
6770
6777
6792
6798
6807
6813
6816
6820
6829
6839
6868
6872
6875
6891
6892
6904
6906
6914
6916
6923
6932
6939
6952
6958
6963
6970
6978
6982
6987
6993
6997
7004
7006
7024
7038
7049
Product: Unison WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan (800 mL)
Model:
#4302
Lot Numbers:
6827

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82645
Status: Resolved
Manufacturer: Inopak Ltd
Sold By: Biocentris Pharmaceuticals; Crosstex International, Inc.; Walter G. Legge Co Inc; National Chemical Laboratories, Inc.
Manufactured In: United States
Units Affected: 10 products (17,850 pounds per batch)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.