Class I - Dangerous
Marketed Without an Approved NDA/ANDA
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Other Drugs
💊 Drugs • 3,313 recalls
CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.
Class I - Dangerous
Marketed Without an Approved NDA/ANDA
Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, menthol 1%), Net Wt. 2.75 oz. (77.3 g) Tube, Distributed by: Ducere Pharma, LLC New Hope, PA 18938 USA --- UPC 849648000023
Dr. Reddy's Laboratories
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle
Class I - Dangerous
Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and the aluminum.
Class I - Dangerous
Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone.
ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso, TX 79912 --- NDC 054365-400-11
Becton Dickinson & Company
Class I - Dangerous
Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep with Tint (Hi Lite Orange)
Failed Stability Specifications
Symbio Muc Eye, 0.17 fl.oz. 5mL bottles, Manufactured for and distributed in the US b: Biological Health Group Corp. Bremerton, WA 98337. NDC 69711-125-61
Deserving Health International
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump
Class I - Dangerous
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
Class I - Dangerous
GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.
Vitamin A&D Ointment (petroleum 93.5%), Skin Protectant, NET Wt. 0.18 OZ (5g), Manufactured for Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 53329-090-16
MEDLINE INDUSTRIES
Class I - Dangerous
Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jelly. The boxes and outer case are correctly labeled as A&D ointment.
Class I - Dangerous
Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk.
Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150. NDC: 0536-1001-85
The Harvard Drug Group
Class I - Dangerous
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Class I - Dangerous
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Class I - Dangerous
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Class I - Dangerous
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Class I - Dangerous
Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufacture for Caverflo Texas Trading -- UPC: 9555671709987
Brian P. Richardson
Class I - Dangerous
Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk