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.

51–66 of 66

SevereFDA (Drugs)··2018-02-28
FDA Recalls Methylcobalamin Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Methylcobalamin (Vitamin B12) for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.
Product
Methylcobalamin (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…
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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 Estriol USP for Prescription Compounding Due to Stability Data Issues
American Pharmaceutical Ingredients LLC is recalling Estriol USP (Micronized) (Yam) for prescription compounding due to a lack of stability data and controls to support expiration dates.
Product
Estriol USP (Micronized) (Yam) for prescription compounding, packaged in a) 5g (NDC 58597-8048-2), b) 25g (NDC 58597-8048-4), c) 100g (NDC 58597-8048-6), 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 Tramadol HCl for Prescription Compounding Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Tramadol HCl USP for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.
Product
Tramadol 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
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0 states
ModerateFDA (Drugs)··2018-02-28
Ursodiol USP Recall Due to Missing Stability Data and Expiration Controls
American Pharmaceutical Ingredients is recalling Ursodiol USP for prescription compounding due to a lack of stability data and controls supporting the assigned expiration dates.
Product
Ursodiol 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
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0 states
ModerateFDA (Drugs)··2018-02-28
American Pharmaceutical Ingredients Recalls Nifedipine USP Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Nifedipine USP for prescription compounding because it lacks stability data to support its expiration dates.
Product
Nifedipine 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
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0 states
ModerateFDA (Drugs)··2018-02-28
American Pharmaceutical Ingredients Recalls Desoximetasone USP Due to Stability Data Deficiencies
American Pharmaceutical Ingredients LLC is recalling Desoximetasone USP (Micronized) for prescription compounding due to a lack of stability data and controls supporting the expiration date.
Product
Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8634-2.
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0 states
ModerateFDA (Drugs)··2018-02-28
Verapamil HCl USP Recalled for Missing Stability Data and Controls
American Pharmaceutical Ingredients LLC is recalling Verapamil HCl USP for prescription compounding due to a lack of stability data and controls supporting the assigned expiration dates.
Product
Verapamil 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
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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
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
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
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
FDA Recalls Doxycycline Hyclate Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Doxycycline Hyclate USP for prescription compounding because it lacks stability data to support its expiration dates.
Product
Doxycycline Hyclate USP for prescription compounding, packaged in a) 25g (NDC 58597-8082-4); b) 100g (NDC 58597-8082-6); c) 500g (NDC 58597-8082-7); d) 1000g (NDC 58597-8082-8), 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
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
Lidocaine USP Recalled Due to Missing Stability Data
American Pharmaceutical Ingredients LLC is recalling Lidocaine USP for prescription compounding because the manufacturer lacks stability data to support the assigned expiration dates.
Product
Lidocaine USP for prescription compounding, packaged in a) 25g (NDC 58597-8019-4); b) 100g (NDC 58597-8019-6); c) 500g (NDC 58597-8019-7); d) 1000 (NDC 58597-8019-8), 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 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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