MUCINEX SE MAX STRENGTH 7CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Family Dollar Stores
Class I - Dangerous
CGMP Deviations: product held outside appropriate storage temperature conditions.
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Other Drugs
💊 Drugs • 3,200 recalls
Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734
Aire-Master of America
Class I - Dangerous
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.
Aire-Master of America
Class I - Dangerous
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606
Aire-Master of America
Class I - Dangerous
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253
Aire-Master of America
Class I - Dangerous
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufactured for B4 Brands, Lisbon, Iowa 62253
Aire-Master of America
Class I - Dangerous
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440
Aire-Master of America
Class I - Dangerous
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZ (510 g) bottle, Bayer Healthcare Pharmaceuticals, NDC 11523-7234-4.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0672-16, b) sodium hypochlorite 0.25%, half strength, NDC 0436-0936-16, c) sodium hypochlorite 0.5% full strength, NDC 0436-0946-16, Antimicrobial, 473 mL (16 fl oz) bottle, Century Pharmaceuticals, Inc.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Alcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box, Manufactured for: Dynarex Corporation, NY 10962, Made in Mexico, NDC 67777-300-01 (current NDC) NDC# 67777-120-10 (discontinued)
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B sulfate, First Aid Antibiotic, Triple Antibiotic Ointment, 144 packets per box, Net wt. per packet 0.5 g, Honeywell Safety Products, NDC 0498-0750-36.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg each, Health Star, NDC 57896-443-01.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Bayer Healthcare Pharmaceutica, NDC 11523-0096-3.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Crest 3D White Fluoride Anticavity Toothpaste, Advanced Triple Whitening, 0.243% sodium fluoride, Net Wt. 5.6 oz (158 g) a) Individual carton, UPC 0 37000 598534; b) 5-count Bundle, UPC 037000171867, Distributed. By Procter & Gamble, Cincinnati, OH 45202.
The Procter & Gamble Company
Class I - Dangerous
Labeling: Missing label: the product tube was missing a label and contained a different formulation.
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Failed Dissolution Specifications
SnoreStop NasoSpray, 0.3 FL OZ (9 mL), Green Pharmaceuticals Inc. Camarillo, CA 93012, NDC 61152-199-99, UPC 7 69682 29101 3
Green Pharmaceuticals
Class I - Dangerous
Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as Providencia rettgeri.
Class I - Dangerous
Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening.