Class I - Dangerous
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
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Prescription Drugs
💊 Drugs • 12,141 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.
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
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.
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
Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.
Mylan Pharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Class I - Dangerous
Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution.
Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.
Mylan Pharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
Class I - Dangerous
Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.