American Pharmaceutical Ingredients LLC recalls

71 recalls on record · latest: March 7, 2018

Official U.S. recall history for American Pharmaceutical Ingredients LLC, compiled from official government records.

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American Pharmaceutical Ingredients LLC recalls Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3

March 7, 2018 · Drug & medication recalls Moderate risk Stability Data Does Not Support Expiry: Stability data from manufacturer does n…

American Pharmaceutical Ingredients LLC recalls Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 585…

March 7, 2018 · Drug & medication recalls Moderate risk Stability Data Does Not Support Expiry: Stability data from manufacturer does n…

Nifedipine USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Calcipotriene BP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Testosterone Cypionate USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Baclofen USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Cyclobenzaprine HCl USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Tadalafil USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Estradiol USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Duloxetine HCl USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Sildenafil Citrate USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Tramadol HCl USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Oxandrolone USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Estradiol Hemihydrate USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Phentolamine Mesylate USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Prilocaine HCl USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Levetiracetam USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Doxycycline Hyclate USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Verapamil HCl USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Ketoconazole USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Biotin USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Tacrolimus USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Ketamine HCl USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Methylcobalamin for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Clonidine HCl USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Nandrolone Decanoate USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Tretinoin USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Desoximetasone USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Cyanocobalamin USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Stanozolol USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Sumatriptan Succinate USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Leucovorin Calcium USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Diclofenac Sodium USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Liothyronine Sodium USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Gabapentin USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Levothyroxine Sodium USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Medroxyprogesterone Acetate USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Pentoxifylline USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Flurbiprofen USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Vancomycin HCl USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Naltrexone HCl USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Vardenafil HCl USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Sumatriptan USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Levofloxacin Hemihydrate USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Clindamycin Phosphate USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Testosterone USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Testosterone Enanthate USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Estrone USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Lincomycin HCl USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Hydroxyprogesterone Caproate USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Lidocaine USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Ursodiol USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Cyclosporine USP recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Celecoxib USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Lidocaine HCl USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Testosterone USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Amitriptyline HCl USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Estriol USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Imiquimod USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Fluticasone propionate USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Anastrozole USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Ketoprofen USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Diphenhydramine HCl USP f recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Progesterone USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Fluconazole USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Ascorbic Acid USP recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Itraconazole USP for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Levocetirizine Dihydrochloride for prescription compounding recalled over manufacturing violations

February 9, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of stability data and controls to support the manufacture…

Doxycycline Hyclate USP recalled over manufacturing violations

June 1, 2017 · Drug & medication recalls Moderate risk Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to…

Methocarbamol recalled over manufacturing violations

May 26, 2017 · Drug & medication recalls Moderate risk CGMP Deviations: Lack of quality assurance at the API manufacturer.

ESTRONE USP recalled over manufacturing violations

April 17, 2017 · Drug & medication recalls Moderate risk cGMP Deviations; lack of quality assurance.