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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 9621–9640 of 17,793 recalls

Class IITerminated

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

American Pharmaceutical Ingredients LLC

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

February 9, 2018 · DrugView details →
Class IITerminated

Phentolamine 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

American Pharmaceutical Ingredients LLC

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

February 9, 2018 · Drug
View details →
Class IITerminated

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

American Pharmaceutical Ingredients LLC

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

February 9, 2018 · DrugView details →
Class IITerminated

Levetiracetam USP for prescription compounding, packaged in a) 500g (NDC 58597-8353-7); b) 1000g (NDC 58597-8353-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

American Pharmaceutical Ingredients LLC

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

February 9, 2018 · DrugView details →
Class IITerminated

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

American Pharmaceutical Ingredients LLC

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

February 9, 2018 · DrugView details →
Class IITerminated

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

American Pharmaceutical Ingredients LLC

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

February 9, 2018 · DrugView details →
Class IITerminated

Ketoconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8053-4); b) 100g (NDC 58597-8053-6); c) 500g (NDC 58597-8053-7) RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

American Pharmaceutical Ingredients LLC

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

February 9, 2018 · DrugView details →
Class IITerminated

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

American Pharmaceutical Ingredients LLC

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

February 9, 2018 · DrugView details →
Class IITerminated

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

American Pharmaceutical Ingredients LLC

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

February 9, 2018 · DrugView details →
Class IITerminated

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

American Pharmaceutical Ingredients LLC

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

February 9, 2018 · DrugView details →
Class IITerminated

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 Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

American Pharmaceutical Ingredients LLC

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

February 9, 2018 · DrugView details →
Class IITerminated

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

American Pharmaceutical Ingredients LLC

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

February 9, 2018 · DrugView details →
Class IITerminated

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

American Pharmaceutical Ingredients LLC

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

February 9, 2018 · DrugView details →
Class IITerminated

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

American Pharmaceutical Ingredients LLC

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

February 9, 2018 · DrugView details →
Class IITerminated

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.

American Pharmaceutical Ingredients LLC

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

February 9, 2018 · DrugView details →
Class IITerminated

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 48327

American Pharmaceutical Ingredients LLC

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

February 9, 2018 · DrugView details →
Class IITerminated

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

American Pharmaceutical Ingredients LLC

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

February 9, 2018 · DrugView details →
Class IITerminated

Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15], Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478

Apace KY LLC

Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.

February 9, 2018 · DrugView details →
Class IITerminated

Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327, NDC 58597-8633-4.

American Pharmaceutical Ingredients LLC

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

February 9, 2018 · DrugView details →
Class IITerminated

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

American Pharmaceutical Ingredients LLC

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

February 9, 2018 · DrugView details →
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