Class I - Dangerous
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
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Other Drugs
💊 Drugs • 3,200 recalls
Class I - Dangerous
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Class I - Dangerous
CGMP Deviations
First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Distributed by: Rugby Laboratories, Indianapolis, IN 46268. Made in China. NDC: 0536-1271-80
Zhejiang Jingwei Pharmaceutical Co.
Class I - Dangerous
Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199
Supercore Products Group
Class I - Dangerous
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bottle, 29 g net fill weight, Distr. by Hikma Specialty USA Inc., Columbus, OH 43328, hikma, Glenmark Specialty SA. NDC 59467-700-27.
Glenmark Pharmaceuticals Inc., USA
Class I - Dangerous
Defective Delivery System: The dip tube is clogged causing the spray not to work.
EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1
EnviroServe Chemicals
Class I - Dangerous
CGMP deviations
Class I - Dangerous
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Class I - Dangerous
Microbial Contamination of Non-Sterile Product
Class I - Dangerous
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Class I - Dangerous
Microbial contamination of non-sterile Products -
CGMP Deviations: sterile water not used for production
CGMP Deviations: sterile water not used for production
Class I - Dangerous
Label mix-up: Carton incorrectly labeled.
Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
MAIN PRODUCTS
Class I - Dangerous
Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
SoloVital
Class I - Dangerous
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Complete 30C/200C Homeopathic Kit, Contains: One hundred 1/2 dram vials of homeopathic medicines, Washington Homeopathic Products, Inc., Berkley Springs, WV 25411, UPC 7 40640 64300 6.
Washington Homeopathic Products
Class I - Dangerous
Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C.
Class I - Dangerous
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class I - Dangerous
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Class I - Dangerous
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.