Class I - Dangerous
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class I - Dangerous
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class I - Dangerous
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Class I - Dangerous
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21
Qualitest Pharmaceuticals
Class I - Dangerous
Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.
Class I - Dangerous
Failed Impurity/Degradation Specification; 12-month stability time point
Glycopyrrolate 0.2 mg/ml, 5 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060, NDC#: 45183-0965-70.
Pharmakon Pharmaceuticals
Class I - Dangerous
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.
del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
Central Admixture Pharmacy Services
Class I - Dangerous
Non Sterility; microbial contamination identified as Aspergillus species
Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68.
Pharmakon Pharmaceuticals
Class I - Dangerous
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
Central Admixture Pharmacy Services
Class I - Dangerous
Non Sterility; microbial contamination identified as Aspergillus species
PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
Central Admixture Pharmacy Services
Class I - Dangerous
Non Sterility; microbial contamination identified as Aspergillus species
MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX
Abrams Royal Pharamacy
Class I - Dangerous
Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis
Class I - Dangerous
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78.
Pharmakon Pharmaceuticals
Class I - Dangerous
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Class I - Dangerous
Customer complaints for failure to deliver the dose.
LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
Central Admixture Pharmacy Services
Class I - Dangerous
Non Sterility; microbial contamination identified as Aspergillus species
All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX
Abrams Royal Pharamacy
Class I - Dangerous
Lack of Assurance of Sterility