2,152 results found for contamination
Page 11 of 87
GFA Production Xiamen Co. Ltd.
Class ITerminated
Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2128
Reason: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
D-0249-2023February 8, 2023Xiamen, N/A
GFA Production Xiamen Co. Ltd.
Class ITerminated
CVS First Aid Home, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 2980-0700
Reason: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
D-0252-2023February 8, 2023Xiamen, N/A
GFA Production Xiamen Co. Ltd.
Class ITerminated
Easy Care first aid Burn Cream (benzalkonium chloride 0.13% and lidocaine hydrochloride 0.5%), 0.9 g (0.03 oz) packets packaged in boxes of 10, Treatment for Burns, Made in China for Adventure Ready B...
Reason: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
Reason: CGMP Deviations: Potential for cross contamination due to product carry over.
D-0064-2023November 23, 2022West Columbia, SC
Adam's Polishes LLC
Class IOngoing
Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / ...
Reason: Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol.
D-0066-2023November 23, 2022Thornton, CO
Nephron Sterile Compounding Center LLC
Class IITerminated
PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233...
Reason: CGMP Deviations: Potential for cross contamination due to product carry over.
D-0065-2023November 23, 2022West Columbia, SC
Ultra Chem Labs Corp
Class IITerminated
Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) ...
Reason: Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
D-0016-2023November 2, 2022Ontario, CA
Ultra Chem Labs Corp
Class IITerminated
Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Green Tea and Aloe, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive ...
Reason: Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
D-0017-2023November 2, 2022Ontario, CA
Salon Technologies International Inc
Class ITerminated
Antica Farmacista Hand Sanitizer Ocean Citron (ethyl alcohol, denatured 65%) packaged in 473 mL/16 fl. oz. bottles, Dist. By Antica Farmacista Seattle, WA 98122 UPC 8 47005 00450 9
Reason: Chemical Contamination: product found to contain benzene
D-0002-2023October 12, 2022Orlando, FL
Vi-Jon, LLC
Class ITerminated
meijer, magnesium citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Dist. By Meijer Distribution, Inc. Grand Rapids, MI 49544; NDC 41250-708-38 UPC 7 13733 4594...
Reason: Microbial contamination of non-sterile products.
D-1504-2022September 21, 2022Smyrna, TN
Vi-Jon, LLC
Class ITerminated
CVS Health, Magnesium Citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), a) UPC 0 50428 30594 2; b) UPC 0 50428 33517 8; Distributed by: CVS Pharmacy, Inc., One ...
Reason: Microbial contamination of non-sterile products.
Reason: Microbial contamination of non-sterile products.
D-1510-2022September 21, 2022Smyrna, TN
Vi-Jon, LLC
Class ITerminated
Topcare health, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Cherry Flavor, 10 FL OZ (296 mL), Distributed By Topco Associates LLC Elk Grove Village, IL 60007; NDC 36800-164-38...
Reason: Microbial contamination of non-sterile products.
D-1508-2022September 21, 2022Smyrna, TN
Edgewell Personal Care Brands, LLC
Class ITerminated
Banana Boat hair & scalp defense, Clear Sunscreen Spray SPF 30, Avobenzone 2.0%, Homosalate 6.0%, Octocrylene 6.0%, packaged in Net Wt 6 oz. aluminum spray can, Distributed by: Edgewell Personal Care ...
Reason: Chemical contamination: presence of benzene
D-0212-2024September 21, 2022Shelton, CT
Vi-Jon, LLC
Class ITerminated
EQUALINE magnesium citrate saline laxative, oral solution, (1.745 g/fl oz), DYE FREE lemon flavor, 10 FL OZ (296 mL), Distributed by Supervalu Inc. Eden Prairie, MN 55344 USA, or Distributed By UNFI ...
Reason: Microbial contamination of non-sterile products.
D-1502-2022September 21, 2022Smyrna, TN
Vi-Jon, LLC
Class ITerminated
equate Magnesium Citrate, SALINE LAXATIVE, (1.745g/fl oz) 10 FL OZ (296mL), Grape Flavor, Distributed By: Walmart, Inc. Bentonville, AR 72716; NDC 49035-592-38 UPC 6 81131 28715 9
Reason: Microbial contamination of non-sterile products.
D-1501-2022September 21, 2022Smyrna, TN
Vi-Jon, LLC
Class ITerminated
Rexall, Magnesium Citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Distributed By Dolgencorp. LLC 100 Mission Ridge, Goodlettsville, TN 37072 or Distributed By...
Reason: Microbial contamination of non-sterile products.
D-1506-2022September 21, 2022Smyrna, TN
Vi-Jon, LLC
Class ITerminated
P, magnesium citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Distributed By Publix Super Markets, Inc. 3300 Publix Corporate Parkway, Lakeland, FL 33811; NDC ...
Reason: Microbial contamination of non-sterile products.
D-1505-2022September 21, 2022Smyrna, TN
Plastikon Healthcare LLC
Class ITerminated
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, ...
Reason: Microbial Contamination of Non-Sterile Products.
D-1478-2022September 14, 2022Lawrence, KS
Plastikon Healthcare LLC
Class ITerminated
Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Ma...
Reason: Microbial Contamination of Non-Sterile Products.
D-1479-2022September 14, 2022Lawrence, KS
Plastikon Healthcare LLC
Class ITerminated
MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suit...
Reason: Microbial Contamination of Non-Sterile Products.
D-1477-2022September 14, 2022Lawrence, KS
Plastikon Healthcare LLC
Class ITerminated
MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suit...
Reason: Microbial Contamination of Non-Sterile Products