Drug and pharmaceutical recalls
17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIFluticasone propionate USP (Micronized) for prescription compounding, packaged in a) 1g (NDC (58597-8276-1), b) 10g (NDC 58597-8276-3), c) 25g (NDC 58597-8276-4), d) 100g (NDC 58597-8276-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IICyanocobalamin USP (Vitamin B12) for prescription compounding, packaged in a) 1g (NDC 58597-8044-1), b) 5g (NDC 58597-8044-2), c) 25g (NDC 58597-8044-4), d) 100g (NDC 58597-8044-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIMethylcobalamin (Vitamin B12) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8056-2); c) 5g (NDC 58597-8056-3); d) 10g (NDC 58597-8056-4), e) 25 g (NDC 58597-8056-4); f) 100g (NDC 58597-8056-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIBiotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8142-2); c) 5g (NDC 58597-8142-3); d ) 25g (NDC 58597-8142-4), Rx only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIAscorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 58597-8120-6); b) 500g (NDC 58597-8120-7); c) 1000g (NDC 58597-8120-8); d) 5000g (NDC 58597-8120-9); e) 25000g (NDC 58597-8120-3), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIVerapamil HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8039-6); b) 500g (NDC 58597-8039-7); c) 1000g (NDC 58597-8039-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIVardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8575-2); b) 100g (NDC 58597-8575-6);c) 500g (NDC 58597-8575-7); d) 1000g (NDC 58597-8575-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIVancomycin HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8091-4); b) 100g (NDC 58597-8091-6); c) 500g (NDC 58597-8091-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIUrsodiol USP for prescription compounding, packaged in a) 100g (NDC 58597-8038-6); b) 500g (NDC 58597-8038-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IITretinoin USP for prescription compounding, packaged in a) 5g (NDC 58597-8033-2); 1b) 10g (NDC 58597-8033-3); c) 25g (NDC 58597-8033-4), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IITramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC 58597-8032-4); b) 100g (NDC 58597-8032-6); c) 500g (NDC 58597-8032-7); d)1000g (NDC 58597-8032-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IITestosterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 25g (NDC 58597-8546-4); b) 100g (NDC 58597-8546-6); c) 500g (NDC 58597-8546-7); d) 1000g (NDC 58597-8546-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IITestosterone Enanthate USP for prescription compounding, packaged in a) 25g (NDC 58597-0079-4); b) 100g (NDC 58597-0079-6); c) 500g (NDC 58597-0079-7); d) 1000g (NDC 58597-0079-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IITestosterone Cypionate USP (Micronized) for prescription compounding, packaged in a)100g (NDC 58597-0078-6); b) 500g (NDC 58597-0078-7); c) 1000g (NDC 58597-0078-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IITestosterone (Soy) (Micronized) USP for prescription compounding, packaged in a) 25g (NDC 58597-0077-4); b) 100g (NDC 58597-0077-6), c) 500g (NDC 58597-0077-7); d)1000g (NDC 58597-0077-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IITadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g (NDC 58597-8538-2); b) 25g (NDC 58597-8538-4); c)100g (NDC 58597-8538-6); d) 500g (NDC 58597-8538-7); d) 1000g (NDC 58597-8538-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IITacrolimus USP (Monohydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8029-4); b) 5g (NDC 58597-8029-5), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IISumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089-3); b) 25g (NDC 58597-8089-4); c)100g (NDC 58597-8089-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IISumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8633-4.
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIStanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-8525-3);b)100g (NDC 58597-8525-6); c) 500g (NDC 58597-8525-7); d)1000g (NDC 58597-8525-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IISildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 58597-8088-2);b) 25g (NDC 58597-8088-4); c) 50g (NDC 58597-8088-5); d) 100g (NDC 58597-8088-6); e) 500g (NDC 58597-8088-7); f)1000g (NDC 58597-8088-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIProgesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8471-1); b) 10g (NDC 58597-8471-3); c) 25g (NDC 58597-8471-4); d) 100g (NDC 58597-8471-6); e) 500g (NDC 58597-8471-7); f) 1000g (NDC 58597-8471-8); g) 5000g (NDC 58597-8471-9), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIPrilocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8028-6); b) 500g (NDC 58597-8028-7); c) 1000g (NDC 58597-8028-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIPhentolamine Mesylate USP for prescription compounding, packaged in a) 1g (NDC 58597-8077-3); b) 5g (NDC 58597-8077-4); c) 500g (NDC 58597-8077-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIPentoxifylline USP for prescription compounding, packaged in a) 25g (NDC 58597-8429-4); b) 100g (NDC 58597-8429-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIOxandrolone USP for prescription compounding, packaged in a) 25g (NDC 58597-0082-4); b)100g (NDC 58597-0082-6); c) 500g (NDC 58597-0082-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IINifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 58597-8025-4); c) 100g (NDC 58597-8025-6); d) 500g (NDC 58597-8025-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IINandrolone Decanoate USP for prescription compounding, packaged in a) 25g (NDC 58597-0081-4); b) 100g (NDC 58597-0081-6); c) 500g (NDC 58597-0081-7); d) 1000g (NDC 58597-0081-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IINaltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g (NDC 58597-8407-1); b) 5g (NDC 58597-8407-2); c) 25g (NDC 58597-8407-4); d) 100g (NDC 58597-8407-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIMedroxyprogesterone Acetate USP (Micronized) for prescription compounding 1000 g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Water ford, MI 48327, NDC 58597-8055-8
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
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