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.

26–50 of 66

ModerateFDA (Drugs)··2018-02-28
FDA Recalls Tretinoin USP for Prescription Compounding Due to Stability Data Gaps
American Pharmaceutical Ingredients LLC is recalling Tretinoin USP for prescription compounding because the manufacturer lacked stability data and controls to support the assigned expiration dates.
Product
Tretinoin 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
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0 states
ModerateFDA (Drugs)··2018-02-28
FDA Recalls Estradiol Hemihydrate Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Estradiol Hemihydrate USP for prescription compounding because it lacks stability data to support its expiration date.
Product
Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, packaged in a) 5g (NDC 58597-8001-3); b) 25g (NDC 58597-8001-5); c)100 g (NDC 58597-8001-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
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0 states
ModerateFDA (Drugs)··2018-02-28
Prilocaine HCl USP Recalled for Lack of Stability Data
American Pharmaceutical Ingredients LLC is recalling Prilocaine HCl USP for prescription compounding due to a lack of stability data supporting expiration dates.
Product
Prilocaine 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
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0 states
ModerateFDA (Drugs)··2018-02-28
FDA Recalls Ketamine HCl USP for Prescription Compounding Due to Stability Data Issues
American Pharmaceutical Ingredients LLC is recalling Ketamine HCl USP for prescription compounding due to a lack of stability data supporting expiration dates.
Product
Ketamine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8333-4); b) 100g (NDC 58597-8333-6); c) 500g (NDC 58597-8333-7); d) 1000g (NDC 58597-8333-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
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0 states
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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0 states
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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0 states
ModerateFDA (Drugs)··2018-02-28
FDA Recalls Diclofenac Sodium USP Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Diclofenac Sodium USP for prescription compounding because it lacks stability data to support expiration dates.
Product
Diclofenac Sodium USP for prescription compounding, packaged in a) 25g (NDC 58597-8012-4); b)100g (NDC 58597-8012-6); c) 500 g (NDC 58597-8012-7); d) 1000g (NDC 58597-8012-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
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0 states
ModerateFDA (Drugs)··2018-02-28
American Pharmaceutical Ingredients Recalls Medroxyprogesterone Acetate Due to Stability Data Gaps
American Pharmaceutical Ingredients is recalling 12,000 grams of Medroxyprogesterone Acetate USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration date.
Product
Medroxyprogesterone 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
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0 states
ModerateFDA (Drugs)··2018-02-28
Pentoxifylline USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Pentoxifylline USP for prescription compounding because it lacks stability data to support its expiration date.
Product
Pentoxifylline 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
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0 states
ModerateFDA (Drugs)··2018-02-28
Flurbiprofen USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients is recalling Flurbiprofen USP for prescription compounding because it lacks stability data to support expiration dates.
Product
Flurbiprofen USP for prescription compounding, packaged in a) 25g (NDC 58597-8075-4); b)100g (NDC 58597-8075-6) ; c) 500g (NDC 58597-8075-7); d) 1000g (NDC 58597-8075-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
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0 states
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
ModerateFDA (Drugs)··2018-02-28
FDA Recalls Clindamycin Phosphate Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Clindamycin Phosphate USP for prescription compounding because the manufacturer lacks stability data to support the assigned expiration dates.
Product
Clindamycin Phosphate USP for prescription compounding, packaged in a) 10g (NDC 58597-8198-3); b) 100g (NDC 58597-8198-6), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
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0 states
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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0 states
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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0 states
ModerateFDA (Drugs)··2018-02-28
Lincomycin HCl USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Lincomycin HCl USP for prescription compounding because it lacks stability data to support its expiration dates.
Product
Lincomycin HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8359-6); b) 500g (NDC 58597-8359-7); c) 1000g (NDC 58597-8359-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
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0 states
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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0 states
ModerateFDA (Drugs)··2018-02-28
American Pharmaceutical Ingredients Recalls Celecoxib USP Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Celecoxib USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.
Product
Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-8635-4); b) 100g (NDC 58597-8635-5); c) 1000g (NDC 58597-8635-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
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0 states
ModerateFDA (Drugs)··2018-02-28
Lidocaine HCl USP Recalled for Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Lidocaine HCl USP for prescription compounding due to a lack of stability data supporting expiration dates.
Product
Lidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8020-6); b) 500g (NDC 58597-8020-7); c) 1000g (NDC 58597-8020-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
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0 states
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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0 states
ModerateFDA (Drugs)··2018-02-28
American Pharmaceutical Ingredients Recalls Imiquimod USP Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Imiquimod USP for prescription compounding due to a lack of stability data and controls supporting expiration dates.
Product
Imiquimod USP for prescription compounding, packaged in a) 1g (NDC 58597-8317-1); b) 10g (NDC 58597-8317-3); c) 25g (NDC 58597-8317-4) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
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0 states
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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0 states
ModerateFDA (Drugs)··2018-02-28
Fluconazole USP Recalled for Lack of Stability Data and Controls
American Pharmaceutical Ingredients LLC is recalling Fluconazole USP for prescription compounding due to CGMP deviations involving missing stability data and controls.
Product
Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4); b) 100g (NDC 58597-8268-6); c)1000g (NDC 58597-8268-8) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
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0 states
ModerateFDA (Drugs)··2018-02-28
American Pharmaceutical Ingredients Recalls Ascorbic Acid Due to Stability Data Gaps
American Pharmaceutical Ingredients LLC is recalling Ascorbic Acid USP for prescription compounding because it lacks stability data to support its expiration dates.
Product
Ascorbic 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 R
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0 states
ModerateFDA (Drugs)··2018-02-28
Sildenafil Citrate USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Sildenafil Citrate USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.
Product
Sildenafil 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 Ingredien
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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 Highlan
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0 states