February 28, 2018DrugsFDA
American Pharmaceutical Ingredients LLC recalls Calcipotriene BP (Monohydrate) for prescription compounding, packaged in a) 250mg (NDC 58597-8630-1); b) 500mg (NDC 5859
Hazard: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
February 28, 2018DrugsFDA
American Pharmaceutical Ingredients LLC recalls Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8004-4); b)100g (NDC 58597-8004-6)
Hazard: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
February 28, 2018DrugsFDA
American Pharmaceutical Ingredients LLC recalls Anastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8080-1), b) 5g (NDC 58597-8080-2), c) 25g (N
Hazard: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
February 28, 2018DrugsFDA
American Pharmaceutical Ingredients LLC recalls Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-8003-4); b) 100 g (NDC 58597-8003-6)
Hazard: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
February 28, 2018DrugsFDA
Nostrum Laboratories Inc recalls Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufactured by Nostrum Laboratories, Inc. Kansas C
Hazard: Presence of Foreign Tablets/Capsules
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Nicardipine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Dexamethasone Sodium Phosphate added to 5% Dextrose in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Rocuronium Bromide in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Methadone HCl Injection in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Meperidine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Esmolol HCl in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Vecuronium Bromide in Sterile Water for Injection in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Neostigmine Methylsulfate Injection in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Labetalol HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Nicardipine HCl in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Ropivacaine HCl Injection in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls HYDROmorphone HCl in 5% Dextrose in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Atropine Sulfate Injection in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Lidocaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Glycopyrrolate in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Ketamine HCl Injection in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Ephedrine Sulfate Injection in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Fentanyl Citrate Injection in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Midazolam HCl Injection in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Methadone HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Labetalol HCl in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Potassium Chloride in 5% Dextrose in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.
February 28, 2018DrugsFDA
Pharmedium Services, LLC recalls Phenylephrine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Hazard: Lack of sterility assurance.