2,152 results found for contamination
Page 15 of 87
Scentsational Soaps & Candles Inc
Class ITerminated
Goose Creek Hand Sanitizer aloe Dragonfruit Splash, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 0...
Reason: Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
D-0677-2021July 28, 2021Venice, FL
Scentsational Soaps & Candles Inc
Class ITerminated
Goose Creek Hand Sanitizer aloe Grape Soda, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 01328 8
Reason: Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
D-0675-2021July 28, 2021Venice, FL
Scentsational Soaps & Candles Inc
Class ITerminated
SS Lavender & Herbs Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL) a) Black and White Collection; b) Photo Real Collection
Reason: Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Reason: Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.
D-0657-2021July 21, 2021Sarasota, FL
Sanit Technologies, LLC dba Durisan
Class ITerminated
Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net Content 0.61 fl oz credit card size container, (UPC 8 52379 0061...
Reason: Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.
D-0656-2021July 21, 2021Sarasota, FL
DIBAR NUTRICIONAL S DE RL DE CV
Class ITerminated
DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distributed by S.E.N.D. LLC, Anthony, NM 88021, Imported by Dibar Labs, LLC, Sugar Land, TX 77479, Made in Mexico,77479, NDC 73009-0...
Reason: Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.
D-0644-2021July 7, 2021Morelia, N/A
CareFusion 213, LLC
Class ITerminated
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is s...
Reason: Microbial Contamination of Non-Sterile Product:.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides,...
D-0346-2021May 5, 2021El Paso, TX
CareFusion 213, LLC
Class ITerminated
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if p...
Reason: Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, ...
D-0345-2021May 5, 2021El Paso, TX
SUN PHARMACEUTICAL INDUSTRIES INC
Class IITerminated
Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473 mL bottles Rx Only, Manufactured by: Mikart, LLC, Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Indust...
Reason: Microbial Contamination of Non-Sterile Product
D-0334-2021April 21, 2021Princeton, NJ
Spartan Chemical Co Inc
Class ITerminated
Lite'n Foamy Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., ...
Reason: Microbial Contamination of Non-Sterile Products; lot tested positive for Bulkholderia multivorans
Reason: Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
D-0324-2021April 14, 2021Weston, FL
Teva Pharmaceuticals USA
Class IITerminated
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva Pharmaceuticals, USA, Inc., Parsippany, NJ Vial NDC 0703-4502-01 (vial) NDC# 0703-4502-04 (tr...
Reason: Chemical contamination; Unknown brown residue adhering to the inside of one vial.
D-0297-2021March 10, 2021Parsippany, NJ
NDAL Mfg Inc.
Class IOngoing
ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray, 1.3 FL OZ (40mL) bottle, 270 measured sprays, Distributed by Ndal Laboratories, 449 Alvarado St., Monterey, CA 93940 (bottle); NDAL MFG...
Reason: Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast
D-0269-2021March 3, 2021Monterey, CA
CareFusion 213, LLC
Class ITerminated
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton. CareFusion El Paso, TX 799...
Reason: Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humi...
D-0267-2021March 3, 2021El Paso, TX
CareFusion 213, LLC
Class ITerminated
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, CareFusion El P...
Reason: Microbial Contamination of Non-Sterile Products:Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humi...
D-0266-2021March 3, 2021El Paso, TX
Liq-E S.A. De C.V.
Class ITerminated
OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 1 Gal (3.78 L) bottle, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexic...
Reason: Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
D-0255-2021February 24, 2021San Nicolas De Los Georgia, N/A
Liq-E S.A. De C.V.
Class ITerminated
OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 55 Gal (208 L) drum, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col.. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. ...
Reason: Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
D-0254-2021February 24, 2021San Nicolas De Los Georgia, N/A
Liq-E S.A. De C.V.
Class ITerminated
OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 275 Gal (1040 L) tank with spout dispenser, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col. La Fe San Nicolas de Los Garza...
Reason: Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
D-0256-2021February 24, 2021San Nicolas De Los Georgia, N/A
Liq-E S.A. De C.V.
Class ITerminated
OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 8.5 Fl. Oz. (250 mL) bottle, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col. La Fe San Nicolas de Los Garza, Nuevo Leon...
Reason: Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
D-0253-2021February 24, 2021San Nicolas De Los Georgia, N/A
Reason: cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testi...
D-0222-2021January 20, 2021Schaumburg, IL
Wishgarden Herbs, Incorporated
Class ITerminated
Cord Care POWDER, 0.25 oz. (7 g) plastic jars, Wishgarden Herbs, Inc., Boulder, CO 80301. UPC 6-56490 24730 4
Reason: Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
D-0219-2021January 6, 2021Louisville, CO
CIPLA
Class IITerminated
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence...
Reason: Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
D-0183-2021January 6, 2021Warren, NJ
CIPLA
Class IITerminated
Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence...
Reason: Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
D-0182-2021January 6, 2021Warren, NJ
Wishgarden Herbs, Incorporated
Class ITerminated
Goldenseal POWDER, 0.25 oz. (7 g) plastic jars, WishGarden Herbs, Inc., Boulder, CO 80301. UPC 6 56490 64137 9
Reason: Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.