Drug and pharmaceutical recalls
17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIClindamycin 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
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IICelecoxib 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
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IICalcipotriene BP (Monohydrate) for prescription compounding, packaged in a) 250mg (NDC 58597-8630-1); b) 500mg (NDC 58597-8630-2); c) 1g (NDC 58597-8630-3), Rx only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIBaclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8004-4); b)100g (NDC 58597-8004-6); c) 500g (NDC 58597-8004-7); d) 1000g (NDC 58597-8004-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIAnastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8080-1), b) 5g (NDC 58597-8080-2), c) 25g (NDC 58597-8080-4), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327.
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIAmitriptyline 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.
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-02-28FDA-DrugNostrum Laboratories IncClass IIICalcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufactured by Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-026-02
Presence of Foreign Tablets/Capsules
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IINicardipine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIDexamethasone Sodium Phosphate added to 5% Dextrose in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIRocuronium Bromide in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIMethadone HCl Injection in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIMeperidine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIEsmolol HCl in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIDexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIVecuronium Bromide in Sterile Water for Injection in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IINeostigmine Methylsulfate Injection in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IILabetalol HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IINicardipine HCl in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIRopivacaine HCl Injection in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIHYDROmorphone HCl in 5% Dextrose in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIAtropine Sulfate Injection in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IILidocaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIGlycopyrrolate in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIRopivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIKetamine HCl Injection in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIEphedrine Sulfate Injection in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIFentanyl Citrate Injection in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIMidazolam HCl Injection in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IIMethadone HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
Lack of sterility assurance.
- 2018-02-28FDA-DrugPharmedium Services, LLCClass IILabetalol HCl in all strengths, all doses, and all packaging.
Lack of sterility assurance.
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