FDA Drug recall D-1312-2019

Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel Instant Waterless Hand Sanitizing Gel with Moisturizers, with…

FDA Drug
Class II
terminated
Published 2019-06-05

On 2019-06-05 the FDA classified a Class II recall of Instant Waterless Hand Sanitizer, Ethyl Alcohol, 62%, packaged as a) DermaGel Instant Waterless Hand Sanitizing Gel with Moisturizers, with… by Inopak, citing CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-1312-2019
Classification	Class II
Status	terminated
Initiated	2019-04-22
Published	2019-06-05
Last updated	2026-09-13 11:52 UTC
Company	Inopak
Distribution	US

Product

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

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

Identifiers

code_info	Batch #: 7069, 6648, 6649, 6652, 6654, 6667, 6669, 6675, 6677, 6684, 6686, 6692, 6694, 6703, 6704, 6710, 6717, 6719, 67… 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.

code_info

Batch #: 7069, 6648, 6649, 6652, 6654, 6667, 6669, 6675, 6677, 6684, 6686, 6692, 6694, 6703, 6704, 6710, 6717, 6719, 67…

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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1312-2019%22

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