February 28, 2018DrugsFDA
American Pharmaceutical Ingredients LLC recalls Methylcobalamin (Vitamin B12) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (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 Biotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8142-2);
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 Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 58597-8120-6); b) 500g (NDC 58597-8120-7); 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 Verapamil HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8039-6); b) 500g (NDC 58597-8039-7); 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 Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2); 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 Vancomycin HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8091-4); b) 100g (NDC 58597-8091-6); 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 Ursodiol USP for prescription compounding, packaged in a) 100g (NDC 58597-8038-6); b) 500g (NDC 58597-8038-7), RX only,
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 Tretinoin USP for prescription compounding, packaged in a) 5g (NDC 58597-8033-2); 1b) 10g (NDC 58597-8033-3); 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 Tramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC 58597-8032-4); b) 100g (NDC 58597-8032-6);
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 Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 25g (NDC 58597-8546-4); b) 100g (NDC 58
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 Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (NDC 58597-0079-4); b) 100g (NDC 58597-0079-
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 Testosterone Cypionate USP (Micronized) for prescription compounding, packaged in a)100g (NDC 58597-0078-6); b) 500g (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 Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in a) 25g (NDC 58597-0077-4); b) 100g (NDC 58
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 Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8538-2); b) 25g (NDC 58597-8538-
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 Tacrolimus USP (Monohydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8029-4); b) 5g (NDC 58597-8029-5
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 Sumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089-3); b) 25g (NDC 58597-8089-4); c)100g (NDC
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 Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American Pharmaceutical Ingredients, LLC
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 Stanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-8525-3);b)100g (NDC 58597-8525-6); c) 500g (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 Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 58597-8088-2);b) 25g (NDC 58597-8088-4); 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 Progesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8471-1); b) 10g (NDC 585
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 Prilocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8028-6); b) 500g (NDC 58597-8028-7); 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 Phentolamine Mesylate USP for prescription compounding, packaged in a) 1g (NDC 58597-8077-3); b) 5g (NDC 58597-8077-4);
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 Pentoxifylline USP for prescription compounding, packaged in a) 25g (NDC 58597-8429-4); b) 100g (NDC 58597-8429-6), 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 Oxandrolone USP for prescription compounding, packaged in a) 25g (NDC 58597-0082-4); b)100g (NDC 58597-0082-6); 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 Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 58597-8025-4); 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.
February 28, 2018DrugsFDA
American Pharmaceutical Ingredients LLC recalls Nandrolone Decanoate USP for prescription compounding, packaged in a) 25g (NDC 58597-0081-4); b) 100g (NDC 58597-0081-6)
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 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.