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Showing 941–960 of 2521 results

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Valsartan 40mg Tablets (Rising) – CGMP Impurity (2019)

CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products

Class IIModerate

FDAMar 7, 2019Nationwide• Rising Pharmaceuticals, Inc.

Valsartan 320mg Tablets (Rising) – CGMP Impurity (2019)

CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products

Class IIModerate

FDAMar 7, 2019Nationwide• Rising Pharmaceuticals, Inc.

ATHLETICARE Hand Soap (Petra Hygienic) – Ingredient Violation (2019)

Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products.

Class IIILow

FDAMar 4, 2019Nationwide• Petra Hygienic Systems Int Ltd

Hydrogen Peroxide Solution (Vi-Jon) – IPA Contamination (2019)

Cross Contamination: Presence of IPA in finished product.

Class IIModerate

FDAFeb 20, 2019IN, OH• Vi-Jon, Inc.

Gel Hand Sanitizer (Ecolab) – Benzene Contamination (2019)

Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

Class IIModerate

FDAFeb 6, 2019Nationwide• Ecolab Inc

Express Gel Hand Sanitizer (Ecolab) – Benzene Contamination (2019)

Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

Class IIModerate

FDAFeb 6, 2019Nationwide• Ecolab Inc

Advanced Gel Hand Sanitizer (Ecolab) – Benzene Contamination (2019)

Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

Class IIModerate

FDAFeb 6, 2019Nationwide• Ecolab Inc

Moisturizing Gel Hand Sanitizer (Ecolab) – Benzene Contamination (2019)

Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

Class IIModerate

FDAFeb 6, 2019Nationwide• Ecolab Inc

Quick-Care Foam Hand Sanitizer (Ecolab) – Benzene Contamination (2019)

Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

Class IIModerate

FDAFeb 6, 2019Nationwide• Ecolab Inc

Melatonin Lozenges (Klaire Labs) – Incorrect filling (2019)

Small quantity of product labeled as Melatonin Lozenge Formula were filled with L-Theanine.

FDAJan 17, 2019IN, KS• ProThera, Inc. dba SFI USA

Cyclosporin Liquid 0.05% (Northwest Compounding) – sterility risk (2019)

Lack of sterility assurance.

Class IIModerate

FDAJan 2, 2019IN, OR• Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Cyclosporin Liquid 0.5% (Northwest Compounding) – sterility risk (2019)

Lack of sterility assurance.

Class IIModerate

FDAJan 2, 2019IN, OR• Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Cyclosporin Liquid 1% (Northwest Compounding) – sterility issues (2019)

Lack of sterility assurance.

Class IIModerate

FDAJan 2, 2019IN, OR• Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Cyclosporin Liquid 2% (Northwest Compounding) – sterility issues (2019)

Lack of sterility assurance.

Class IIModerate

FDAJan 2, 2019IN, OR• Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Cyclosporin Liquid 0.2% (Northwest Compounding) – sterility concerns (2019)

Lack of sterility assurance.

Class IIModerate

FDAJan 2, 2019IN, OR• Hiers Enterprises, LLC dba Northwest Compounding Pharmacy

Amlodipine/Valsartan Tablets (Aurobindo) – NDEA impurity (2018)

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Class IIModerate

FDADec 31, 2018Nationwide• Aurobindo Pharma USA Inc.

Infant Snowsuit (Children's Place) – Choking Risk (2018)

This recall involves girls' infant snowsuits sold in infant sizes 0 to 18 months. The recalled snowsuits were sold in two styles and three colors/patterns. The style number is printed on a label sewn in to the side seam. The snowsuits are 100% polyester and the trim is 95% polyester and 5% spandex. They have matching print hoods with small ears, detachable mittens and a zipper down the front of the suit covered with a fabric snap flap at the chest. Style Number Colors/Pattern 2111187 White Sophy floral - a white snowsuit with a pattern of flowers of different colors 2111187 Jazzberry ladybug - a pink snowsuit with a pattern of red ladybugs 2111188 Rosebud heart - a pale pink snowsuit with a heart pattern stitched in to the sleeves

CPSCDec 18, 2018Nationwide

Lubrisine Eye Drops (Results RNA) – undeclared silver (2018)

Undeclared Allergen

Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver

FDADec 14, 2018Nationwide• Results RNA, LLC

Falls Creek Kids Hoodies – Choking Risk (2018)

This recall involves Falls Creek Kids branded children's zip up hoodies sold in five color styles in sizes 12M,18M, 24M, 2T,3T 4T and 5T. "Falls Creek Kids" and "Made in China" are printed on the inner collar. The tracking number is printed on a sewn-in label on the inner side seam. Product Sizes Tracking Number Color/Style Falls Creek Kids zip up hoodies 12M, 18M, 24M, 2T, 3T, 4T and 5T "MAY 2018 17677," "MAY 2018 17506," or "AUGUST 2018 17932" navy with white and orange striped sleeves teal with white and navy striped sleeves gray with a football play graphic olive green with a bear graphic gray girl's hoodie with ruffled trim

CPSCDec 6, 2018Nationwide

Tuo Convertible High Chair – Fall Risk (2018)

This recall involves Skip Hop's Tuo convertible high chairs with charcoal gray or silver/white with clouds fabric. They have a reversible seat pad, removable tray, 5-point harness, beechwood footrest and legs. The high chairs can be converted into a toddler chair. One of the following style numbers and corresponding date code can be found on the back of the chair: Style Number Date Codes 304200 (charcoal gray) HH5/2017, HH6/2017, HH7/2017, HH8/2017, HH9/2017, HH092717, HH092917, HH010518, HH010518, HH030518, HH05182018, HH05182018, HH05312018, 304201 (silver/white with clouds) HH5/2017, HH6/2017, HH7/2017, HH8/2017, HH9/2017, HH092717, HH092917, HH010518, HH010518, HH030518, HH05182018, HH05182018, HH05312018

CPSCDec 6, 2018Nationwide

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