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American Pharmaceutical Ingredients Recalls
71 recalls on record · June 21, 2017 to March 21, 2018 · Drugs
Recalls by year
17
18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 28, 2018DrugsFDA
American Pharmaceutical Ingredients LLC recalls Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8407-1); b) 5g (NDC 58597-8407
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 Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 1000 g, RX only, packed by American Pharmaceut
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 Liothyronine Sodium USP for prescription compounding ,1g, RX only, packed by American Pharmaceutical Ingredients, LLC 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 Lincomycin HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8359-6); b) 500g (NDC 58597-8359-7); c)
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 Lidocaine USP for prescription compounding, packaged in a) 25g (NDC 58597-8019-4); b) 100g (NDC 58597-8019-6); c) 500g (
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 Lidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8020-6); b) 500g (NDC 58597-8020-7); c) 1
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 Levothyroxine Sodium USP for prescription compounding, packaged in a) 1g (NDC 58597-8638-1); b) 5 g (NDC 58597-8638-2),
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 Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100g (NDC 58597-8085-6); b) 1000g (NDC 58597-8
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 Levocetirizine Dihydrochloride for prescription compounding, packaged in a) 25g (NDC 58597-8355-6); b) 100g (NDC 58597-8
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 Levetiracetam USP for prescription compounding, packaged in a) 500g (NDC 58597-8353-7); b) 1000g (NDC 58597-8353-8), RX
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 Leucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC 58597-8084-1); b) 1g (NDC 58597-8084-3); c
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 Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8336-4); b) 100g (NDC 58597-8336
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 Ketoconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8053-4); b) 100g (NDC 58597-8053-6); c) 50
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 Ketamine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8333-4); b) 100g (NDC 58597-8333-6); c) 500
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 Itraconazole USP (Micronized) for prescription compounding, packaged in a) 10g (NDC 58597-8133-3); b) 25g (NDC 58597-81
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 Imiquimod USP for prescription compounding, packaged in a) 1g (NDC 58597-8317-1); b) 10g (NDC 58597-8317-3); c) 25g (ND
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 Hydroxyprogesterone Caproate USP for prescription compounding, packaged in a) 25g (NDC 58597-8051-4); b) 100g (NDC 58597
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 Gabapentin USP for prescription compounding, packaged in a) 25g (NDC 58597-8014-4); b) 100g (NDC 58597-8014-6); c) 500
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 Flurbiprofen USP for prescription compounding, packaged in a) 25g (NDC 58597-8075-4); b)100g (NDC 58597-8075-6) ; c) 500
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 Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4); b) 100g (NDC 58597-8268-6); c)1000g
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 Estrone USP for prescription compounding, packaged in a) 5 g (NDC 58597-8049-3); b) 100mg (NDC 58597-8049-1); c) 25 g (
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 Estriol USP (Micronized) (Yam) for prescription compounding, packaged in a) 5g (NDC 58597-8048-2), b) 25g (NDC 58597-80
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 Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, packaged in a) 5g (NDC 58597-8001-3); b) 25g
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 Estradiol USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8047-1); b) 5g (NDC 58597-80
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 Duloxetine HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8632-6); b)1000 g (NDC 58597-8632-8), RX
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 Doxycycline Hyclate USP for prescription compounding, packaged in a) 25g (NDC 58597-8082-4); b) 100g (NDC 58597-8082-6);
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 Diphenhydramine HCl USP f (or prescription compounding , packaged in a) 25g ( NDC 58597-8081-4); b) 100g (NDC 58597-8081
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 Diclofenac Sodium USP for prescription compounding, packaged in a) 25g (NDC 58597-8012-4); b)100g (NDC 58597-8012-6); c)
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 Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, packed by American Pharmaceutical Ingredient
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 Cyclosporine USP, for prescription compounding, packaged in a) 5g (NDC 58597-8210-2); b) 10g (NDC 58597-8210-3); c) 100g
Hazard: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.