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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 Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8011-4), b)100g (NDC 58597-8011-6);
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 Clonidine HCl USP for prescription compounding, packaged in a) 5g (NDC 58597-8010-2); b) 10g (NDC 58597-8010-3); c) 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 Clindamycin Phosphate USP for prescription compounding, packaged in a) 10g (NDC 58597-8198-3); b) 100g (NDC 58597-8198-6
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 Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-8635-4); b) 100g (NDC 58597-8635-5); 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 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.
July 12, 2017DrugsFDA
American Pharmaceutical Ingredients LLC recalls Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 58597-8023-7), c) 1,000
Hazard: CGMP Deviations: Lack of quality assurance at the API manufacturer.
July 5, 2017DrugsFDA
American Pharmaceutical Ingredients LLC recalls Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc container (NDC: 58597-8082-4),
Hazard: Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
June 21, 2017DrugsFDA
American Pharmaceutical Ingredients LLC recalls ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8
Hazard: cGMP Deviations; lack of quality assurance.