FDA (Drugs) recall action 82645

Inopak Ltd recalled 10 products on 2019-06-05

The FDA (Drugs) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.

Products: 10
Announced: 2019-06-05
Critical: 0
Units: —

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

1–10 of 10

ModerateFDA (Drugs)··2019-06-05
Inopak Antibacterial Hand Soap Recalled for CGMP Deviations
Inopak Ltd is recalling specific batches of Antibacterial Hand Soap because they were not produced under current good manufacturing practices.
Product
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,
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0 states
ModerateFDA (Drugs)··2019-06-05
Inopak Recalls INOFOAM Food Handling Wash for CGMP Deviations
Inopak Ltd is recalling INOFOAM Foaming E-2 Food Handling Wash because it was not produced under current good manufacturing practices.
Product
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.
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0 states
ModerateFDA (Drugs)··2019-06-05
Inopak Recalls Antibacterial Foaming Hand Wash for CGMP Deviations
Inopak Ltd is recalling specific batches of Antibacterial Foaming Hand Wash because they were not produced under current good manufacturing practices.
Product
ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a) 18 oz bottles, 12/18 oz bottles per case, 5063-432-02; b) 1 gallon bottles, 4/1 gallon bottles per case, 5063-420-03; c) Options Systems Antibacterial Foaming H
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0 states
ModerateFDA (Drugs)··2019-06-05
Inopak Recalls Antibacterial Hand Soap Due to Manufacturing Deviations
Inopak Ltd is recalling specific batches of Healthcare 2000 antibacterial hand soap because they were not produced under current good manufacturing practices.
Product
Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhexidine Gluconate), 4 x (1 gallon containers), Reorder/REF #JSCG; Manufactured for Crosstex International, Inc.; b) MEDI-WASH CHG Anti-Microbial Hand Wash with C
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0 states
ModerateFDA (Drugs)··2019-06-05
Inopak Recalls Inoderm Antiseptic Hand Soap Due to Manufacturing Deviations
Inopak Ltd is recalling Inoderm Antiseptic Hand Soap because it was not produced under current good manufacturing practices.
Product
INODERM Antiseptic Hand Soap (E-2), .6% (incorrectly labeled on bags as 75%) PCMX, 800ml/27fl.oz.pouches (NDC 058575-110), 12 x 800 Bag-N-Box pouches per case (NDC 058575-110-80), 5014-404-NB; INOPAK, 24 Executive PKWY, Ringwood, NJ 07456.
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0 states
ModerateFDA (Drugs)··2019-06-05
Inopak Recalls Sani-Guard-SF Foam Hand Sanitizer Due to Manufacturing Deviations
Inopak Ltd is recalling Sani-Guard-SF Waterless Foam Hand Sanitizer because it was not produced under current good manufacturing practices.
Product
Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000, b) 1000 ml cartridge pouch, 6/1000 ml .8ml Option Cartridge pouches per case, 5068-OS1000, Inopak LTD
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0 states
ModerateFDA (Drugs)··2019-06-05
Inopak Recalls Mild Health Care Antibacterial Hand Soap for CGMP Deviations
Inopak Ltd is recalling Mild Health Care Antibacterial Hand Soap because it was not produced under current good manufacturing practices.
Product
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
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0 states
ModerateFDA (Drugs)··2019-06-05
Inopak Recalls AQUACIL Hand Sanitizer Due to Manufacturing Deviations
Inopak Ltd is recalling specific batches of AQUACIL instant foaming hand sanitizer because they were not produced under current good manufacturing practices.
Product
AQUACIL instant foaming hand sanitizer, alcohol free formula, benzalkonium chloride 0.1% (w/w), packaged in a) 18 FL OZ (532 mL) bottles, 12/18OZ bottles per case, Product Code BIO-5075-432-02; b) 1000 ML pouches, 6/1000 ML pouches per case, Product Code BIO575-OS1000, Biocentris
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0 states
ModerateFDA (Drugs)··2019-06-05
Inopak Recalls Unison Hand Cleaner for Manufacturing Practice Violations
Inopak Ltd is recalling Unison Hand Care Products due to production not meeting current good manufacturing practices.
Product
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 N
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0 states
ModerateFDA (Drugs)··2019-06-05
Inopak Recalls Hand Sanitizer Due to Manufacturing Practice Deviations
Inopak Ltd is recalling DermaGel and SaniTyze hand sanitizers because they were not produced under current good manufacturing practices.
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-L
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0 states