Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2021-08-11FDA-DrugCascade Kelly Holdings LLCClass IIGlobal Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 8 fl. oz./236 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-02
CGMP Deviations: Does not meet monograph for denaturant.
- 2021-08-11FDA-DrugCascade Kelly Holdings LLCClass IIGlobal Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 4 fl. oz./119 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-01
CGMP Deviations: Does not meet monograph for denaturant.
- 2021-08-04FDA-DrugAPI Solutions Inc.Class IIAzelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne Alabama Manufactured by: Yicheng Chemicals Corp. China Distributed by: Syntec Pharma Corp New York
cGMP Deviations
- 2021-08-04FDA-DrugAPI Solutions Inc.Class IIEstriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendship Rd Daphne, AL Distributed by: Syntec Pharma Corp., NY MFT by: Wuhan Fortune Chemical Co., Ltd., China, NDC: 46144-300-01
cGMP Deviations
- 2021-07-28FDA-DrugInnoveix Pharmaceuticals IncClass IICompounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Lack of Assurance of Sterility
- 2021-07-28FDA-DrugInnoveix Pharmaceuticals IncClass IICompounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Lack of Assurance of Sterility
- 2021-07-28FDA-DrugTeligent Pharma, Inc.Class IIIErythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(NDC 52565-033-60) Rx Only, Manufactured by: Teligent Pharma, Inc. , Buena, NJ 08310,
Failed Impurities/Degradation Specifications
- 2021-07-28FDA-DrugTeligent Pharma, Inc.Class IIIErythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59
Failed Impurities/Degradation Specifications
- 2021-07-28FDA-DrugNuri Trading LLCClass I69MODE Blue 69 capsule, packaged in 10-count box, Nuri Trading LLC
Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making it an unapproved drug for which the safety and efficacy have not been established and therefore subject to recall.
- 2021-07-28FDA-DrugNuri Trading LLCClass IThumbs Up 7 White 11K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil sildenafil, and vardenafil, FDA approved drugs making them an unapproved drug for which the safety and efficacy have not been established and therefore subject to recall.
- 2021-07-28FDA-DrugNuri Trading LLCClass IThumbs Up 7 Black 25K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil, an FDA approved drug making this an unapproved drug for which the safety and efficacy has not been established and therefore subject to recall.
- 2021-07-28FDA-DrugNuri Trading LLCClass IShogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass ICoconut Stand CoCo TKO Hand Sanitizer, Totally Knocks Out 99.9% of Germs, 3.4 FL. OZ. (100.55 mL), Distributed by: Beauty Sparks LLC St. Petersburg, FL 33711
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose Creek Hand Sanitizer aloe Tropical Daydream, 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 01335 6
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose Creek Hand Sanitizer aloe Watermelon Lemonade, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 814630 02423 3
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose Creek Hand Sanitizer aloe Red, White & Blue Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 14630 02045 7
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose Creek Hand Sanitizer aloe Optimistic Vibes, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 14630 02234 5
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose Creek Hand Sanitizer aloe Melon Picnic, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 14630 02424 0
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose Creek Hand Sanitizer aloe Marshmallows, 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 01331 8
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose 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 01332 5
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose Creek Hand Sanitizer aloe Champagne Bubbles, 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 01334 9
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose 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
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose Creek Hand Sanitizer aloe Beach Dreams, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandles.com, 1498 S. Wallace Wilkinson Blvd. Liberty, KY 42539, UPC 8 18489 01336 3
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose Creek Hand Sanitizer aloe Limoncello, 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 01333 2
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose Creek Hand Sanitizer aloe Blueberry Limeade, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd. Liberty, KY 42539, UPC 8 14630 02049 5
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass ISS Tangerine & Guava Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL) a) Black and White Collection; b) Photo Real Collection
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass ISS Lemon Zest Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL) a) Black and White Collection; b) Photo Real Collection
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass ISS 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
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass ISS Eucalyptus Mint Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL), a) Black and White Collection; b) Photo Real Collection
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass ISS Coconut Breeze Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL), a) Black and White Collection; b) Photo Real Collection
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
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