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dermarite industries, llc

21 recalls on record

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DermaRite Industries, LLC — DermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in a) 106 g (3.75 oz.) per tube (NDC 61924-174-04) and b) 454 g (16 oz.) per jar (NDC 61924-174-16

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

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DermaRite Industries, LLC — Hand-E-Foam, Benzethonium Chloride 0.20%, packaged in a) 236mL (NDC 61924-102-08) and b) 1000 mL (NDC 61924-102-34) per container, DermaRite Industries LLC, 7777 West Side

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

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DermaRite Industries, LLC — Renew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), and c) 800 mL (NDC 61924-405-27), DermaRite Industrie

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

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DermaRite Industries, LLC — Lantiseptic, Dry Skin Therapy, Lanolin USP 30%, packaged in a) 5 g (0.17 oz) (NDC 61924-504-05), b) 4 oz (NDC 61924-504-04), and c)14 oz (NDC 61924-710-14) tubes, DermaRite

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

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DermaRite Industries, LLC — 4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

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DermaRite Industries, LLC — Lantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c) 4oz (NDC 61924-304-04), d) 4.5oz (NDC

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

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DermaRite Industries, LLC — KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

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DermaRite Industries, LLC — DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g (3.75 oz.) per tube (NDC 61924-234-04) Der

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

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DermaRite Industries, LLC — DermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

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DermaRite Industries, LLC — PeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

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DermaRite Industries, LLC — DermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

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DermaRite Industries, LLC — PeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b) 3.5oz (NDC 61924-205-04), and c) 7oz (NDC 61924-205-07) tubes, DermaRite Industries LLC, 7777

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

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DermaRite Industries, LLC — Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-435-04

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

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DermaRite Industries, LLC — DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) p

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

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DermaRite Industries, LLC — San-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-107-34

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

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DermaRite Industries, LLC — UltraSure Anti-Perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 mL (4 fl. oz.), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

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DermaRite Industries, LLC — GelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and c) 800 mL (NDC 61924-106-27), and d) 1000 mL (NDC 61

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

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DermaRite Industries, LLC — DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

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DermaRite Industries, LLC — DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol 0.2%), packaged in a) 800 ml (27 fl. oz.) bag-n-box (NDC 61924-092-27) and b) 1000ml (34 fl. o

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

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DermaRite Industries, LLC — KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.

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DermaRite Industries, LLC — PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-

Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.