Fentanyl Citrate Injection in all strengths, all doses, and all packaging.
Pharmedium Services
Class I - Dangerous
Lack of sterility assurance.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Oxandrolone 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
American Pharmaceutical Ingredients
Class I - Dangerous
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Labetalol HCl in all strengths, all doses, and all packaging.
Pharmedium Services
Class I - Dangerous
Lack of sterility assurance.
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
Class I - Dangerous
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class I - Dangerous
Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
Ephedrine Sulfate Injection in all strengths, all doses, and all packaging.
Pharmedium Services
Class I - Dangerous
Lack of sterility assurance.
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
Class I - Dangerous
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
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
Class I - Dangerous
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Ketamine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Pharmedium Services
Class I - Dangerous
Lack of sterility assurance.
Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Pharmedium Services
Class I - Dangerous
Lack of sterility assurance.
Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and packaging.
Pharmedium Services
Class I - Dangerous
Lack of sterility assurance.
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
Class I - Dangerous
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
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
Class I - Dangerous
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
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
Class I - Dangerous
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
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
Class I - Dangerous
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Pharmedium Services
Class I - Dangerous
Lack of sterility assurance.
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
Class I - Dangerous
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
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
Class I - Dangerous
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
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
Class I - Dangerous
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class I - Dangerous
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.