🔍 RecallPedia

Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel Instant Waterless Hand Sanitizing Gel with Moisturizers, with Aloe Vera & Vitamin E, packaged in a) 1000 ml Disc Pump pouches (NDC 58575-340), 8 x 1000 ml Disc Pump pouches per case, Product Code 5025-L1000; b) 2 fl. oz. bottles, 80/2 oz bottles per case, 5025-480-02; c) 18 fl. oz. bottles (NDC 58575-340), 16/18 oz bottles per case, 5025-430-02; d) 8 FL OZ. bottle, 24/8 oz bottle per case, 5025-440-03; e) 4 fl. oz. bottles, 24 x 4oz. Bottles per case, 5025-450-03; f) 800 ml pouches, 12 x 800 ml Universal Valve pouches per case, 5025-404-NB; g) 1 Gallon bottles, 4/1 gallon bottles per case, 5025-4202-02; Inopak LTD., Ringwood, NJ 07456. SaniTyze Hand Sanitizer with Aloe Vera, Vitamin E & Keratin, packaged as h) 8 fl oz (237 ml) bottles, 24/ 8 Oz. bottles per case; Manufactured for Crosstex International, Inc., 10 Rarick Road, Hauppague, NY 11788-4209.

Class I - Dangerous
💊 Drugs Recalled: April 22, 2019 Inopak Other Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Batch #: 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, 6843, 6845, 6852, 6859, 6860, 6874, 6878, 6880, 6881, 6884, 6889, 6897, 6900, 6903, 6905, 6912, 6920, 6922, 6926, 6928, 6931, 6940, 6945, 6948, 6951, 6954, 6962, 6967, 6969, 6972, 6975, 6980, 6986, 6989, 6995, 7002, 7015, 7023, 7029, 7030, 7035, 7044, 7047, 7048, 7051, 7059, 7062, 7066, 7072, 7073, 7079, 7081, 7084, 7085, 7088, 7090, 7095, 7096, 7099, 7102, 7105, 7112, 7113, 7115, 7124, 7125, and 7128.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Inopak Ltd
Reason for Recall:
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel Instant Waterless Hand Sanitizing Gel with Moisturizers, with Aloe Vera & Vitamin E, packaged in a) 1000 ml Disc Pump pouches (NDC 58575-340), 8 x 1000 ml Disc Pump pouches per case, Product Code 5025-L1000; b) 2 fl. oz. bottles, 80/2 oz bottles per case, 5025-480-02; c) 18 fl. oz. bottles (NDC 58575-340), 16/18 oz bottles per case, 5025-430-02; d) 8 FL OZ. bottle, 24/8 oz bottle per case, 5025-440-03; e) 4 fl. oz. bottles, 24 x 4oz. Bottles per case, 5025-450-03; f) 800 ml pouches, 12 x 800 ml Universal Valve pouches per case, 5025-404-NB; g) 1 Gallon bottles, 4/1 gallon bottles per case, 5025-4202-02; Inopak LTD., Ringwood, NJ 07456. SaniTyze Hand Sanitizer with Aloe Vera, Vitamin E & Keratin, packaged as h) 8 fl oz (237 ml) bottles, 24/ 8 Oz. bottles per case; Manufactured for Crosstex International, Inc., 10 Rarick Road, Hauppague, NY 11788-4209.

Product Codes/Lot Numbers:

Batch #: 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, 6843, 6845, 6852, 6859, 6860, 6874, 6878, 6880, 6881, 6884, 6889, 6897, 6900, 6903, 6905, 6912, 6920, 6922, 6926, 6928, 6931, 6940, 6945, 6948, 6951, 6954, 6962, 6967, 6969, 6972, 6975, 6980, 6986, 6989, 6995, 7002, 7015, 7023, 7029, 7030, 7035, 7044, 7047, 7048, 7051, 7059, 7062, 7066, 7072, 7073, 7079, 7081, 7084, 7085, 7088, 7090, 7095, 7096, 7099, 7102, 7105, 7112, 7113, 7115, 7124, 7125, and 7128.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1312-2019

Related Recalls

Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 ml Disc Pump pouches, 8 x 1000 ml Disc Pump pouches per case, 5013-L1000, b) 2000 ml. Disc Pump pouches, 4 x 2000 ml Disc Pump pouches per case, 5013-XL2000, c) 800 ml Universal Valve pouches, 12 x 800 ml Universal Valve pouches per case, 5013-404, d) 1 gallon bottles, 4/1 gallon bottles per case, 5013-420-02, INOPAK, LTD., 24 Executive Parkway, Ringwood, NJ 07456.

Inopak

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Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with Triclosan, #4302, with exclusive Bajan fragrance, packaged in 800 ML (27 FL OZ) pouch containers, 12-800 ml containers/12-27 FL. OZ. container pouches per case, National Chemical Laboratories, Inc., 401 North 10th Street, Philadelphia, PA 19123.

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Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soap with moisturizers, a) 1000 ml pouches, 10/1000 ML. Large Valve pouches per case, 5031-404-LN, b) 1000 ml pouches, 8/1000 ML. Disc Pumps pouches per case, 5031-L1000, c) 800 ML Universal Valve pouches, 12/800 ML Universal Valve pouches per case, 5031-404, d) 800 ml pouches, 12/800 ML Presspak pouches per case, "B", 5031-403-1B, e) 800 ml pouches, 12 x 800ML. KC Valve pouches per case, 5031-404-KC, f) 800 ml pouches, 12/800 ML Universal Valve pouches per case, 5031-404, g) 800 ml pouches, 12/800 ML Presspak pouches per case, "B", 5031-403-1B, h) 500 ml pouches, 6/500 ML. KC Valve pouches per case, 5031-404-500-6, i) 500 ml pouches, 18/500 ML. KC Valve pouches per case, 5031-404-500, j) 500 ml pouches, 6/500 ML. KC Valve pouches per case, 5031-404-500-6, k) 8 oz. bottles, 24/8 OZ. bottles with pumps per case, 5031-440-03, l) 18 oz. bottles, 16 x 18 OZ. Bottles with Pumps per case, 5031-430-02, m) 1000 ml pouches, 10/1000 ML. Large Valve pouches per case, 5031-404-LN, n) 1000 ml pouches, 8/1000ML. Disc Pumps pouches per case, 5031-L1000; Choice Antibacterial Hand Soap, packaged as o) 800 ml/27fl.oz. pouches, 12/800 ml Universal Valve pouches per case, 5031-404UV-CH, Manufactured by Inopak LTD., Ringwood, NJ.

Inopak

Class I - Dangerous

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

Apr 22, 2019 Other Drugs Nationwide View Details →