American Pharmaceutical Ingredients recalls
FDA enforcement reports naming American Pharmaceutical Ingredients LLC as the recalling firm.
- Recall reports
- 71
- Class I (serious)
- 0
- Most recent report
- Mar 21, 2018
- Mar 21, 2018Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical IngredientsDrug · American Pharmaceutical Ingredients LLCStability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.Class II
- Mar 21, 2018Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-…Drug · American Pharmaceutical Ingredients LLCStability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.Class II
- Feb 28, 2018Anastrozole USP for prescription compounding, packaged in a) 1g ( NDC 58597-8080-1), b)…Drug · American Pharmaceutical Ingredients LLCCGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.Class II
- Feb 28, 2018Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-8…Drug · American Pharmaceutical Ingredients LLCCGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.Class II
- Feb 28, 2018Calcipotriene BP (Monohydrate) for prescription compounding, packaged in a) 250mg (NDC…Drug · American Pharmaceutical Ingredients LLCCGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.Class II
- Feb 28, 2018Celecoxib USP for prescription compounding, packaged in a) 25g (NDC 58597-8635-4)Drug · American Pharmaceutical Ingredients LLCCGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.Class II
- Feb 28, 2018Clindamycin Phosphate USP for prescription compounding, packaged in a) 10g (NDC 58597-8…Drug · American Pharmaceutical Ingredients LLCCGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.Class II
- Feb 28, 2018Clonidine HCl USP for prescription compounding, packaged in a) 5g (NDC 58597-8010-2)Drug · American Pharmaceutical Ingredients LLCCGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.Class II
- Feb 28, 2018Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-801…Drug · American Pharmaceutical Ingredients LLCCGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.Class II
- Feb 28, 2018Cyclosporine USP, for prescription compounding, packaged in a) 5g (NDC 58597-8210-2)Drug · American Pharmaceutical Ingredients LLCCGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.Class II
- Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, packed by A…
- Diclofenac Sodium USP for prescription compounding, packaged in a) 25g (NDC 58597-8012-4)
- Diphenhydramine HCl USP f (or prescription compounding , packaged in a) 25g ( NDC 58597…
- Doxycycline Hyclate USP for prescription compounding, packaged in a) 25g (NDC 58597-808…
- Duloxetine HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8632-6)
- Estradiol USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (NDC 5…
- Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, packaged in…
- Estriol USP (Micronized) (Yam) for prescription compounding, packaged in a) 5g (NDC 58…
- Estrone USP for prescription compounding, packaged in a) 5 g (NDC 58597-8049-3)
- Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8268-4)
- Flurbiprofen USP for prescription compounding, packaged in a) 25g (NDC 58597-8075-4)
- Gabapentin USP for prescription compounding, packaged in a) 25g (NDC 58597-8014-4)
- Hydroxyprogesterone Caproate USP for prescription compounding, packaged in a) 25g (NDC…
- Imiquimod USP for prescription compounding, packaged in a) 1g (NDC 58597-8317-1)
- Itraconazole USP (Micronized) for prescription compounding, packaged in a) 10g (NDC 58…
- Ketamine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8333-4)
- Ketoconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8053-4)
- Ketoprofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597…
- Leucovorin Calcium USP for prescription compounding, packaged a) 100mg, (NDC 58597-808…
- Levetiracetam USP for prescription compounding, packaged in a) 500g (NDC 58597-8353-7)
- Levocetirizine Dihydrochloride for prescription compounding, packaged in a) 25g (NDC 58…
- Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100g (NDC 585…
- Levothyroxine Sodium USP for prescription compounding, packaged in a) 1g (NDC 58597-863…
- Lidocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8020-6)
- Lidocaine USP for prescription compounding, packaged in a) 25g (NDC 58597-8019-4)
- Lincomycin HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8359-6)
- Liothyronine Sodium USP for prescription compounding ,1g, RX only, packed by American…
- Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 1000 g, RX on…
- Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g (NDC 585…
- Nandrolone Decanoate USP for prescription compounding, packaged in a) 25g (NDC 58597-00…
- Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2)
- Oxandrolone USP for prescription compounding, packaged in a) 25g (NDC 58597-0082-4)
- Pentoxifylline USP for prescription compounding, packaged in a) 25g (NDC 58597-8429-4)
- Phentolamine Mesylate USP for prescription compounding, packaged in a) 1g (NDC 58597-80…
- Prilocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8028-6)
- Progesterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 1g (N…
- Sildenafil Citrate USP for prescription compounding, packaged in a) 5g (NDC 58597-8088-2)
- Stanozolol USP for prescription compounding, packaged in a) 25g (NDC 58597-8525-3)
- Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by America…
- Sumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089-3)
- Tacrolimus USP (Monohydrate) for prescription compounding, packaged in a) 1g (NDC 58597…
- Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g (NDC 58597…
- Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in a) 25g (N…
- Testosterone Cypionate USP (Micronized) for prescription compounding, packaged in a)10…
- Testosterone Enanthate USP for prescription compounding, packaged in a) 25g (NDC 58597-…
- Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 25g (N…
- Tramadol HCl USP (CIV) for prescription compounding, packaged in a) 25g (NDC 58597-803…
- Tretinoin USP for prescription compounding, packaged in a) 5g (NDC 58597-8033-2)
- Ursodiol USP for prescription compounding, packaged in a) 100g (NDC 58597-8038-6)
- Vancomycin HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8091-4)
- Vardenafil HCl USP (trihydrate) for prescription compounding, packaged in a) 5g (NDC 58…
- Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-800…
- Methylcobalamin (Vitamin B12) for prescription compounding, packaged in a) 500mg (NDC 5…
- Cyanocobalamin USP (Vitamin B12) for prescription compounding, packaged in a) 1g (NDC 5…
- Fluticasone propionate USP (Micronized) for prescription compounding, packaged in a) 1g…
- Verapamil HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8039-6)
- Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 58597-8120-6)
- Biotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (NDC 58597-8…
- Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g contain…
- Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 c…
- ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-804…
Page 1 of 8