August 11, 2021DrugsFDA
Pfizer Inc. recalls Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10
Hazard: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
August 11, 2021DrugsFDA
Pfizer Inc. recalls Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets),
Hazard: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
August 11, 2021DrugsFDA
Pfizer Inc. recalls Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY
Hazard: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
August 11, 2021DrugsFDA
Cascade Kelly Holdings LLC recalls Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 8 fl. oz./236 mL, Al
Hazard: CGMP Deviations: Does not meet monograph for denaturant.
August 11, 2021DrugsFDA
Cascade Kelly Holdings LLC recalls Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 4 fl. oz./119 mL, Al
Hazard: CGMP Deviations: Does not meet monograph for denaturant.
August 4, 2021DrugsFDA
API Solutions Inc. recalls Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne Alabama Manufactured by: Yicheng Chemicals
Hazard: cGMP Deviations
August 4, 2021DrugsFDA
API Solutions Inc. recalls Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendship Rd Daphne, AL Distributed by: Syntec Ph
Hazard: cGMP Deviations
July 28, 2021DrugsFDA
Innoveix Pharmaceuticals Inc recalls Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addi
Hazard: Lack of Assurance of Sterility
July 28, 2021DrugsFDA
Innoveix Pharmaceuticals Inc recalls Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: In
Hazard: Lack of Assurance of Sterility
July 28, 2021DrugsFDA
Teligent Pharma, Inc. recalls Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(NDC 52565-033-60) Rx Only, Manufactured by:
Hazard: Failed Impurities/Degradation Specifications
July 28, 2021DrugsFDA
Teligent Pharma, Inc. recalls Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59
Hazard: Failed Impurities/Degradation Specifications
July 28, 2021DrugsFDA
Nuri Trading LLC recalls 69MODE Blue 69 capsule, packaged in 10-count box, Nuri Trading LLC
Hazard: 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.
July 28, 2021DrugsFDA
Nuri Trading LLC recalls Thumbs Up 7 White 11K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
Hazard: 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.
July 28, 2021DrugsFDA
Nuri Trading LLC recalls Thumbs Up 7 Black 25K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
Hazard: 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.
July 28, 2021DrugsFDA
Nuri Trading LLC recalls Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
Hazard: 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.
July 28, 2021DrugsFDA
Scentsational Soaps & Candles Inc recalls Coconut Stand CoCo TKO Hand Sanitizer, Totally Knocks Out 99.9% of Germs, 3.4 FL. OZ. (100.55 mL), Distributed by: Beaut
Hazard: Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
July 28, 2021DrugsFDA
Scentsational Soaps & Candles Inc recalls Goose Creek Hand Sanitizer aloe Tropical Daydream, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCre
Hazard: Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
July 28, 2021DrugsFDA
Scentsational Soaps & Candles Inc recalls Goose Creek Hand Sanitizer aloe Watermelon Lemonade, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseC
Hazard: Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
July 28, 2021DrugsFDA
Scentsational Soaps & Candles Inc recalls Goose Creek Hand Sanitizer aloe Red, White & Blue Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCree
Hazard: Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
July 28, 2021DrugsFDA
Scentsational Soaps & Candles Inc recalls Goose Creek Hand Sanitizer aloe Optimistic Vibes, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCree
Hazard: Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
July 28, 2021DrugsFDA
Scentsational Soaps & Candles Inc recalls Goose Creek Hand Sanitizer aloe Melon Picnic, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCan
Hazard: Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
July 28, 2021DrugsFDA
Scentsational Soaps & Candles Inc recalls Goose Creek Hand Sanitizer aloe Marshmallows, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCan
Hazard: Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
July 28, 2021DrugsFDA
Scentsational Soaps & Candles Inc recalls Goose Creek Hand Sanitizer aloe Dragonfruit Splash, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCr
Hazard: Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
July 28, 2021DrugsFDA
Scentsational Soaps & Candles Inc recalls Goose Creek Hand Sanitizer aloe Champagne Bubbles, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCre
Hazard: Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
July 28, 2021DrugsFDA
Scentsational Soaps & Candles Inc recalls Goose Creek Hand Sanitizer aloe Grape Soda, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandl
Hazard: Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
July 28, 2021DrugsFDA
Scentsational Soaps & Candles Inc recalls Goose Creek Hand Sanitizer aloe Beach Dreams, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCan
Hazard: Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
July 28, 2021DrugsFDA
Scentsational Soaps & Candles Inc recalls Goose Creek Hand Sanitizer aloe Limoncello, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL),Goose Creek www.GooseCreekCandle
Hazard: Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
July 28, 2021DrugsFDA
Scentsational Soaps & Candles Inc recalls Goose Creek Hand Sanitizer aloe Blueberry Limeade, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCre
Hazard: Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
July 28, 2021DrugsFDA
Scentsational Soaps & Candles Inc recalls SS Tangerine & Guava Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL) a) B
Hazard: Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
July 28, 2021DrugsFDA
Scentsational Soaps & Candles Inc recalls SS Lemon Zest Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL) a) Black an
Hazard: Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.