PlainRecalls
FDA Drug Moderate Class II Terminated

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. bot

Reported: June 5, 2019 Initiated: April 22, 2019 #D-1312-2019

Product 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.

Reason for Recall

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

Details

Recalling Firm
Inopak Ltd
Units Affected
17,850 pounds per batch
Distribution
Nationwide in the USA
Location
Ringwood, NJ

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Inopak Ltd. Units affected: 17,850 pounds per batch.
Why was this product recalled? ▼
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 5, 2019. Severity: Moderate. Recall number: D-1312-2019.

Related Recalls

CPSC Moderate

Meijer Recalls Lullaby Lane and MCS Children's Sleepwear Due to Burn Hazard; Violates Mandatory Standard for Children's…

· 2026-02-19
FDA Food Moderate

Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Passion Fruit- UPC# 5061033691882

Diva Fam Inc · 2026-02-11
FDA Food Moderate

Repackaged M&Ms candies, Net Wt 1.3 oz. Item BB458BG. Labeled with the following promotional company names. 1. Nex…

Beacon Promotions Inc · 2026-02-11
FDA Food Critical

Sofit, Seedless Red Dates, 12 oz package, Plastic bags, 50 packages per case

Tai Phat Wholesalers, LLC · 2026-02-11
FDA Food Moderate

Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Wildcrafted- UPC# 5065006235073

Diva Fam Inc · 2026-02-11

Explore Related Data

Vehicle Safety → Drug Information →