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Showing 5,081–5,100 of 17,937 drug recalls
Drug RecallOngoingHistorical recordClass II
Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0469-56
by Pfizer Inc.
Reason
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0468-56
by Pfizer Inc.
Reason
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Global 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
by Cascade Kelly Holdings LLC
Reason
CGMP Deviations: Does not meet monograph for denaturant.
Recall initiated
June 30, 2021
Reported by FDA
August 11, 2021
Distribution
Distributed to the firm's affiliated facilities and donated third party recipients located in the following states: CT, MA, ME, ND, NY, OR, PA, TX, VT.
Global 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
by Cascade Kelly Holdings LLC
Reason
CGMP Deviations: Does not meet monograph for denaturant.
Recall initiated
June 30, 2021
Reported by FDA
August 11, 2021
Distribution
Distributed to the firm's affiliated facilities and donated third party recipients located in the following states: CT, MA, ME, ND, NY, OR, PA, TX, VT.
69MODE Blue 69 capsule, packaged in 10-count box, Nuri Trading LLC
by Nuri Trading LLC
Reason
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.
Coconut 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
by Scentsational Soaps & Candles Inc
Reason
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Goose 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
by Scentsational Soaps & Candles Inc
Reason
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Goose 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
by Scentsational Soaps & Candles Inc
Reason
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Goose 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
by Scentsational Soaps & Candles Inc
Reason
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
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
by Scentsational Soaps & Candles Inc
Reason
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Goose 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
by Scentsational Soaps & Candles Inc
Reason
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
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
by Scentsational Soaps & Candles Inc
Reason
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
SS 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
by Scentsational Soaps & Candles Inc
Reason
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680.
by Ummzy, LLC
Reason
Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA, UPC 118122030185
by Ummzy, LLC
Reason
Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
