Drug and pharmaceutical recalls
17628 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2015-11-25FDA-DrugDowning Labs, LLCClass IITaurine Injectable, 50mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Lack of Assurance of Sterility
- 2015-11-25FDA-DrugDowning Labs, LLCClass IIMethylcobalamin Buffered Injectable, 1mg/mL, packaged in a) 10mL vial, b) 30mL Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Lack of Assurance of Sterility
- 2015-11-25FDA-DrugDowning Labs, LLCClass IIVitamin D3 Injectable, 10,000 U/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Lack of Assurance of Sterility
- 2015-11-25FDA-DrugDowning Labs, LLCClass IICo-Enzyme Q-10 Injectable, 20mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Lack of Assurance of Sterility
- 2015-11-25FDA-DrugDowning Labs, LLCClass IIProcaine Injectables 20mg/mL and 2%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Lack of Assurance of Sterility
- 2015-11-25FDA-DrugDowning Labs, LLCClass IIRiboflavin-5-Phosphate Injectable,10mg/mL, 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Lack of Assurance of Sterility
- 2015-11-25FDA-DrugDowning Labs, LLCClass IIMICML TRNDPPC Injection (Preserved) 10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Lack of Assurance of Sterility
- 2015-11-25FDA-DrugDowning Labs, LLCClass IIAscorbic Acid Injectable 500mg/mL, packaged in a) 10mL vials, b) 50mL vials, c)100mL vials, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Lack of Assurance of Sterility
- 2015-11-25FDA-DrugDowning Labs, LLCClass IIAcetyl-L-Carnitine Injectable, 100mg/mL, 30mL vial, L-Carnitine Injection 500mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Lack of Assurance of Sterility
- 2015-11-25FDA-DrugDowning Labs, LLCClass IIEDTA Disodium Injectable, 150mg/mL, 100mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Lack of Assurance of Sterility
- 2015-11-25FDA-DrugDowning Labs, LLCClass IIL-Tryptophan Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Lack of Assurance of Sterility
- 2015-11-25FDA-DrugDowning Labs, LLCClass IIL-Tyrosine Injectable, 25mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Lack of Assurance of Sterility
- 2015-11-25FDA-DrugDowning Labs, LLCClass IIL-Glutamine Injectable, 30mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Lack of Assurance of Sterility
- 2015-11-25FDA-DrugBlue Square Market, Inc.Class IKABOOM action strips, Sexual Performance Strips, packaged in 6.4oz box 12 strips per box, Nutrology USA LLC
Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil.
- 2015-11-25FDA-DrugBlue Square Market, Inc.Class ILiDa DAIDAIHUA (also packaged as LiDa DAIDAIHUAJIAONANG), capsules, packaged in 1.6oz box 30 capsules per box, Kunming Dali Industry & Trade Co., Ltd
Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein.
- 2015-11-25FDA-DrugAkorn, Inc.Class IIIHydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10
Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.
- 2015-11-25FDA-DrugUS Compounding IncClass IIZinc Sulfate (1 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3226-07
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- 2015-11-25FDA-DrugUS Compounding IncClass IIVoriconazole Solution (1%(10 mg/mL), 15 mL dropper bottle; For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-2815-10
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- 2015-11-25FDA-DrugUS Compounding IncClass IIVitamin D3 in Olive Oil (50,000 IU/mL) 30 mL vial, For IM Use only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3277-06
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- 2015-11-25FDA-DrugUS Compounding IncClass IIVancomycin Ophthalmic PF 0.5 mL (5 mg/0.5 mL (10 mg/mL), 1 mL syringe, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-0209-64
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- 2015-11-25FDA-DrugUS Compounding IncClass IITropicamide 1%/Phenylephrine 2.5% (tropicamide USP 10 mg/ phenylephrine HCL USP 25 mg), 10 mL Ophthalmic Dropper, For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3214-07
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- 2015-11-25FDA-DrugUS Compounding IncClass IITropicamide 0.5%/ Phenylephrine 5%, 2 mL Dropper Bottle For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3298-02
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- 2015-11-25FDA-DrugUS Compounding IncClass IITri-Mix 30/1/10 (papaverine HCL USP 30 mg/ phentolamine mesylate USP 1 mg/ alprostadil USP 10 mcg/mL), 5 mL Multi-Dose Vial, For Penile Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3256-05
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- 2015-11-25FDA-DrugUS Compounding IncClass IITriamcinolone diacetate USP PF (40 mg/mL), 2 mL Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3206-01
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- 2015-11-25FDA-DrugUS Compounding IncClass IITriamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3205-06
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- 2015-11-25FDA-DrugUS Compounding IncClass IITriamcinolone/Lidocaine (40 mg/1%/mL), 10 mL Multidose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3204-07
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- 2015-11-25FDA-DrugUS Compounding IncClass IITriamcinolone acetonide, USP (50 mg/mL), 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3203-07
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- 2015-11-25FDA-DrugUS Compounding IncClass IITrace Elements-4 (Zinc Sulfate heptahydrate 4.39 mg, Cupric Sulfate pentahydrate 1.57 mg, Manganese Sulfate monohydrate USP 0.308 mg, Chromic Chloride hexahydrate USP 0.0205 mg), 10 mL Multi-Dose Vial, For IV Injection After Dilution, Dilute Before IV Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3201-07
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- 2015-11-25FDA-DrugUS Compounding IncClass IITestosterone EO-Pro-Cyp 220 (220 mg/mL) 30 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2169-06
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- 2015-11-25FDA-DrugUS Compounding IncClass IITestosterone cypionate, USP (250 mg/mL), 10 mL Multi-Dose Vial, For Deep IM Injection Only, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-2131-07
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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