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
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Made in the USA, Deb USA, Inc., Charlotte, NC 28217, NDC 11084-010-27.
S.C. Johnson Professional
Class I - Dangerous
CGMP Deviations: Product was released to market prior to microbiological testing.
Class I - Dangerous
Lack of Assurance of Sterility
Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906 NDC 68703-206-02
Silver Star Brands
Class I - Dangerous
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Microbial Contamination of Non-Sterile Product
Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection, Rx Only, Tailor Made Compounding, Nicholasville, KY 40356
Tailor Made Compounding
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expiration date
Native Remedies VertiFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-253-02
Silver Star Brands
Class I - Dangerous
Microbial Contamination of Non-Sterile Products
Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1352-05
Pharm D Solutions
Class I - Dangerous
Lack of Assurance of Sterility
HCG Lyopholized 1200 IU Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-1743-12
Pharm D Solutions
Class I - Dangerous
Lack of Assurance of Sterility
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/20 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1366-02
Pharm D Solutions
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class I - Dangerous
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Sermorelin/GHRP-2 18 mg/6 mg powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1748-10
Pharm D Solutions
Class I - Dangerous
Lack of Assurance of Sterility
Bi-Mix Injection, (Alprostadil 40 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1305-03
Pharm D Solutions
Class I - Dangerous
Lack of Assurance of Sterility
Irbesartan Bulk Active Pharmaceutical Ingredient.
Aurobindo Pharma Limited (Unit I)
Class I - Dangerous
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.