Drug and pharmaceutical recalls
17732 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 IICalcium Gluconate (680mOsm/L) Injection 10%, 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 IITNPDR Injection Buffered, 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 IIGreen Tea (EGCG) 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 IIMagnesium Sulfate Injectable, 14.28%, 7mL 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 IIDMPS Injectable, 50mg/mL, 5mL 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 IITNPRDC Injection, 6 mL 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 Calcium Disodium Injectable, 300mg/mL, 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 IIChromium Injectable, 200mg/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 IIHCG (Lyophilized) Injectable, 5000 units/vial, 5mL 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, 5mg/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 IIPhosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 10/4.75%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/2.5%; Phosphatidylcholine/Deoxycholic Acid Injection (Preserved) 50 ML 5/4.2%, 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 IIGlucosamine HCL Injectable, 200mg/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 IICyanocobalamin Buffered Injectable 3mg/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 IIMagnesium Sulfate 50% Injectable, 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 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.
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