American Pharmaceutical Ingredients recalls

American Pharmaceutical Ingredients appears in 71 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• Tacrolimus USP (Monohydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8029-4)
  FDA Drug · Class II · 2018-02-28 · American Pharmaceutical Ingredients
  Reason: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
• Lincomycin HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8359-6)
  FDA Drug · Class II · 2018-02-28 · American Pharmaceutical Ingredients
  Reason: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
• Ketoconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8053-4)
  FDA Drug · Class II · 2018-02-28 · American Pharmaceutical Ingredients
  Reason: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
• Stanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-8525-3);b)100g (NDC 58597-8525-6)
  FDA Drug · Class II · 2018-02-28 · American Pharmaceutical Ingredients
  Reason: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
• Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8538-2)
  FDA Drug · Class II · 2018-02-28 · American Pharmaceutical Ingredients
  Reason: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
• Cyclosporine USP, for prescription compounding, packaged in a) 5g (NDC 58597-8210-2)
  FDA Drug · Class II · 2018-02-28 · American Pharmaceutical Ingredients
  Reason: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
• Levothyroxine Sodium USP for prescription compounding, packaged in a) 1g (NDC 58597-8638-1)
  FDA Drug · Class II · 2018-02-28 · American Pharmaceutical Ingredients
  Reason: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
• Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4)
  FDA Drug · Class II · 2018-02-28 · American Pharmaceutical Ingredients
  Reason: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
• Imiquimod USP for prescription compounding, packaged in a) 1g (NDC 58597-8317-1)
  FDA Drug · Class II · 2018-02-28 · American Pharmaceutical Ingredients
  Reason: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
• Calcipotriene BP (Monohydrate) for prescription compounding, packaged in a) 250mg (NDC 58597-8630-1)
  FDA Drug · Class II · 2018-02-28 · American Pharmaceutical Ingredients
  Reason: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
• Itraconazole USP (Micronized) for prescription compounding, packaged in a) 10g (NDC 58597-8133-3)
  FDA Drug · Class II · 2018-02-28 · American Pharmaceutical Ingredients
  Reason: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
• Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8336-4)
  FDA Drug · Class II · 2018-02-28 · American Pharmaceutical Ingredients
  Reason: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
• Diclofenac Sodium USP for prescription compounding, packaged in a) 25g (NDC 58597-8012-4)
  FDA Drug · Class II · 2018-02-28 · American Pharmaceutical Ingredients
  Reason: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
• Tramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC 58597-8032-4)
  FDA Drug · Class II · 2018-02-28 · American Pharmaceutical Ingredients
  Reason: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
• Nandrolone Decanoate USP for prescription compounding, packaged in a) 25g (NDC 58597-0081-4)
  FDA Drug · Class II · 2018-02-28 · American Pharmaceutical Ingredients
  Reason: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
• Fluticasone propionate USP (Micronized) for prescription compounding, packaged in a) 1g (NDC (58597-8276-1), b) 10g (NDC 58597-8276-3), c)…
  FDA Drug · Class II · 2018-02-28 · American Pharmaceutical Ingredients
  Reason: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
• Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2)
  FDA Drug · Class II · 2018-02-28 · American Pharmaceutical Ingredients
  Reason: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
• Vancomycin HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8091-4)
  FDA Drug · Class II · 2018-02-28 · American Pharmaceutical Ingredients
  Reason: CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
• Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 58597-8023-7), c) 1,000 g container (NDC: 5…
  FDA Drug · Class II · 2017-07-12 · American Pharmaceutical Ingredients
  Reason: CGMP Deviations: Lack of quality assurance at the API manufacturer.
• Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc container (NDC: 58597-8082-4), b) 100 g packaged in…
  FDA Drug · Class II · 2017-07-05 · American Pharmaceutical Ingredients
  Reason: Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
• ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescri…
  FDA Drug · Class II · 2017-06-21 · American Pharmaceutical Ingredients
  Reason: cGMP Deviations; lack of quality assurance.