Class I - Dangerous
Lack of Assurance of Sterility
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Lack of Assurance of Sterility
Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Safe-T-Fresh Inc., USA, 2530 Xenium Lane North, Minneapolis, MN 55441.
S.C. Johnson Professional
Class I - Dangerous
CGMP Deviations: Product was released to market prior to microbiological testing.
Class I - Dangerous
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility; bags have the potential to leak
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility; bags have the potential to leak
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Class I - Dangerous
Lack of Assurance of Sterility
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Native Remedies HypoSlim Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-275-02
Silver Star Brands
Class I - Dangerous
Microbial Contamination of Non-Sterile Products
Class I - Dangerous
Lack of Assurance of Sterility
Native Remedies EyeClear Pro Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-151-59
Silver Star Brands
Class I - Dangerous
Microbial Contamination of Non-Sterile Product
Class I - Dangerous
Lack of Assurance of Sterility
BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in normject syringe) Repackaged by Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix, AZ 85085. NDC 42852-001-24
Avella of Deer Valley, Inc. Store 38
Class I - Dangerous
Lack of Assurance of Sterility
Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90 mg, 120-count bottles, Rx only, Distributed by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-99
Orexigen Therapeutics
Class I - Dangerous
Container packaging defect.
Healthful Naturals DizziFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-204-02
Silver Star Brands
Class I - Dangerous
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.