Class I - Dangerous
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
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Other Drugs
💊 Drugs • 3,200 recalls
Class I - Dangerous
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Class I - Dangerous
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Class I - Dangerous
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10
B. Braun Medical
Class I - Dangerous
Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. The presence of sildenafil and tadalafil makes AMPT Natural Herbal Coffee an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Additionally, this product has been found to contain undeclared milk, milk is recognized as one of the foods reported to have caused deaths due to anaphylactic shock in persons with underlying hypersensitivities.
Class I - Dangerous
Marketed Without an Approved NDA/ANDA
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.