FDA (Drugs) recall action 79149

American Pharmaceutical Ingredients LLC recalled 66 products on 2018-02-28

The FDA (Drugs) publishes a recall like this one as 66 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 66 pages.

Products: 66
Announced: 2018-02-28
Critical: 0
Units: 5,186,964

Why these products were recalled

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–25 of 66

ModerateFDA (Drugs)··2018-02-28
FDA Recalls Testosterone USP Micronized for Prescription Compounding
American Pharmaceutical Ingredients LLC is recalling Testosterone USP (Micronized) (Yam) for prescription compounding due to CGMP deviations regarding stability data and expiration date controls.
Product
Testosterone 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…
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ModerateFDA (Drugs)··2018-02-28
Levofloxacin Hemihydrate Recalled for Lack of Stability Data
American Pharmaceutical Ingredients is recalling Levofloxacin Hemihydrate USP for prescription compounding due to missing stability data supporting expiration dates.
Product
Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100g (NDC 58597-8085-6); b) 1000g (NDC 58597-8085-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
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ModerateFDA (Drugs)··2018-02-28
Biotin USP Recalled for Lack of Stability Data and Controls
American Pharmaceutical Ingredients LLC is recalling Biotin USP for prescription compounding due to CGMP deviations, specifically a lack of stability data and controls to support expiration dates.
Product
Biotin 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
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ModerateFDA (Drugs)··2018-02-28
American Pharmaceutical Ingredients Recalls Tacrolimus USP Due to Stability Data Gaps
American Pharmaceutical Ingredients is recalling specific lots of Tacrolimus USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.
Product
Tacrolimus 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
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ModerateFDA (Drugs)··2018-02-28
American Pharmaceutical Ingredients Recalls Gabapentin USP for Prescription Compounding
American Pharmaceutical Ingredients LLC is recalling Gabapentin USP for prescription compounding due to a lack of stability data and controls to support assigned expiration dates.
Product
Gabapentin USP for prescription compounding, packaged in a) 25g (NDC 58597-8014-4); b) 100g (NDC 58597-8014-6); c) 500g (NDC 58597-8014-7); d) 1000g (NDC 58597-8014-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
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ModerateFDA (Drugs)··2018-02-28
Amitriptyline HCl USP Recalled for Lack of Stability Data
American Pharmaceutical Ingredients is recalling Amitriptyline HCl USP for prescription compounding due to a lack of stability data supporting the assigned expiration dates.
Product
Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-8003-4); b) 100 g (NDC 58597-8003-6); c) 500 g (NDC 58597-8003-7), d) 1000 g (NDC 58597-8003-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
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ModerateFDA (Drugs)··2018-02-28
Naltrexone HCl USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Naltrexone HCl USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.
Product
Naltrexone 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
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ModerateFDA (Drugs)··2018-02-28
FDA Recalls Estrone USP for Prescription Compounding Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Estrone USP for prescription compounding because it lacks stability data and controls to support its expiration dates.
Product
Estrone USP for prescription compounding, packaged in a) 5 g (NDC 58597-8049-3); b) 100mg (NDC 58597-8049-1); c) 25 g (NDC 58597-8049-4), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
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ModerateFDA (Drugs)··2018-02-28
Nandrolone Decanoate USP Recalled for Lack of Stability Data
American Pharmaceutical Ingredients LLC is recalling Nandrolone Decanoate USP for prescription compounding due to a lack of stability data supporting expiration dates.
Product
Nandrolone 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
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ModerateFDA (Drugs)··2018-02-28
FDA Recalls Vitamin B12 Compounding Ingredient Due to Stability Data Gaps
American Pharmaceutical Ingredients LLC is recalling Cyanocobalamin USP for prescription compounding because it lacks stability data to support its expiration dates.
Product
Cyanocobalamin 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…
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0 states
ModerateFDA (Drugs)··2018-02-28
Tadalafil USP Recall Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Tadalafil USP for prescription compounding due to a lack of stability data supporting expiration dates.
Product
Tadalafil 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…
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ModerateFDA (Drugs)··2018-02-28
American Pharmaceutical Ingredients Recalls Stanozolol USP Due to CGMP Deviations
American Pharmaceutical Ingredients LLC is recalling Stanozolol USP for prescription compounding due to lack of stability data and controls supporting expiration dates.
Product
Stanozolol 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
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ModerateFDA (Drugs)··2018-02-28
Clonidine HCl USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Clonidine HCl USP for prescription compounding because it lacks stability data to support its expiration date.
Product
Clonidine HCl USP for prescription compounding, packaged in a) 5g (NDC 58597-8010-2); b) 10g (NDC 58597-8010-3); c) 25g (NDC 58597-8010-4); d)100g (NDC 58597-8010-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
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ModerateFDA (Drugs)··2018-02-28
Liothyronine Sodium USP Recalled for Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Liothyronine Sodium USP for prescription compounding due to a lack of stability data supporting the expiration date.
Product
Liothyronine Sodium USP for prescription compounding ,1g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8021-2.
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ModerateFDA (Drugs)··2018-02-28
FDA Recalls Vancomycin HCl Due to Missing Stability Data
American Pharmaceutical Ingredients is recalling Vancomycin HCl USP for prescription compounding because it lacks stability data to support its expiration dates.
Product
Vancomycin 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
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0 states
SevereFDA (Drugs)··2018-02-28
FDA Recalls Estradiol USP for Compounding Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Estradiol USP (Micronized) (Yam) for prescription compounding due to a lack of stability data and controls to support assigned expiration dates.
Product
Estradiol USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 58597-8047-1); b) 5g (NDC 58597-8047-3); c) 10g (NDC 58597-8047-4); d) 25g (NDC 58597-8047-5); e) 100 g (NDC 58597-8047-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650…
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ModerateFDA (Drugs)··2018-02-28
American Pharmaceutical Ingredients Recalls Levothyroxine Sodium Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling specific lots of Levothyroxine Sodium USP for prescription compounding due to a lack of stability data and controls to support the assigned expiration dates.
Product
Levothyroxine Sodium USP for prescription compounding, packaged in a) 1g (NDC 58597-8638-1); b) 5 g (NDC 58597-8638-2), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
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ModerateFDA (Drugs)··2018-02-28
Levocetirizine Dihydrochloride Recalled for Lack of Stability Data
American Pharmaceutical Ingredients LLC is recalling Levocetirizine Dihydrochloride for prescription compounding due to a lack of stability data supporting the expiration date.
Product
Levocetirizine Dihydrochloride for prescription compounding, packaged in a) 25g (NDC 58597-8355-6); b) 100g (NDC 58597-8355-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
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ModerateFDA (Drugs)··2018-02-28
FDA Recalls Itraconazole USP for Prescription Compounding Due to Stability Data Issues
American Pharmaceutical Ingredients LLC is recalling Itraconazole USP for prescription compounding because it lacks stability data to support its expiration dates.
Product
Itraconazole USP (Micronized) for prescription compounding, packaged in a) 10g (NDC 58597-8133-3); b) 25g (NDC 58597-8133-4); c)100g (NDC 58597-8133-6); d) 1000g (NDC 58597-8133-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI…
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ModerateFDA (Drugs)··2018-02-28
Fluticasone Propionate USP Recalled for Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Fluticasone propionate USP for prescription compounding due to a lack of stability data and controls to support expiration dates.
Product
Fluticasone 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…
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ModerateFDA (Drugs)··2018-02-28
Cyclosporine USP Recalled for Lack of Stability Data and Controls
American Pharmaceutical Ingredients LLC is recalling Cyclosporine USP for prescription compounding due to CGMP deviations regarding stability data and expiration date controls.
Product
Cyclosporine USP, for prescription compounding, packaged in a) 5g (NDC 58597-8210-2); b) 10g (NDC 58597-8210-3); c) 100g, NDC 58597-8210-6; d) 500g (NDC 58597-8210-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
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SevereFDA (Drugs)··2018-02-28
FDA Recalls Vardenafil HCl for Prescription Compounding Due to Stability Data Gaps
American Pharmaceutical Ingredients LLC is recalling Vardenafil HCl USP for prescription compounding due to a lack of stability data and controls supporting the assigned expiration dates.
Product
Vardenafil 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…
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ModerateFDA (Drugs)··2018-02-28
FDA Recalls Testosterone for Compounding Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Testosterone (Soy) (Micronized) USP for prescription compounding due to a lack of stability data and controls supporting expiration dates.
Product
Testosterone (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…
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ModerateFDA (Drugs)··2018-02-28
FDA Recalls Diphenhydramine HCl Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Diphenhydramine HCl USP f due to a lack of stability data supporting the assigned expiration date.
Product
Diphenhydramine HCl USP f (or prescription compounding , packaged in a) 25g ( NDC 58597-8081-4); b) 100g (NDC 58597-8081-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
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ModerateFDA (Drugs)··2018-02-28
FDA Recalls Leucovorin Calcium Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Leucovorin Calcium USP for prescription compounding because it lacks stability data to support its expiration dates.
Product
Leucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC 58597-8084-1); b) 1g (NDC 58597-8084-3); c) 5g (NDC 58597-8084-4); d) 25 g (NDC 58597-8084-5), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
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