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.

2019-03-27FDA-DrugIso-Tex Diagnostics, IncClass II
Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8.
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
2019-03-27FDA-DrugRx Pak Division of McKesson CorporationClass II
Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards, For institutional use only, Mfg by: Aenova Holding GmBh, Miami, Fl 33186, NDC 63739-0478-10
Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.
2019-03-27FDA-DrugTeva Pharmaceuticals USAClass III
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets each), Rx only, Manufactured in Israel By: Teva Pharmaceutical Ind. Ltd. Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0093-3008-93
Subpotent Drug.
2019-03-20FDA-DrugMylan Institutional IncClass I
Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 U.S.A., Made in India. NDC: 67457-601-30
Presence of Particulate Matter: particulate matter identified as copper salts
2019-03-20FDA-DrugMedtech Products, Inc.Class II
Little Remedies New Baby Essentials Kit. Each kit contains 1 each of the following products: Little Remedies Infant Fever Reducer (acetaminophen 150mg) 2 fl. oz. bottle, Little Remedies Saline Spray/Drops (sodium chloride) 0.5 fl oz., Little Remedies Gripe Water (zingiber officinale (Ginger) Root Extract 5mg, Foeniculum vulgare (Fennel) Seed Extract 4 mg) 2 fl. oz bottle., Little Remedies Gas Relief Drops (simethicone emulsion USP 66.7 mg and simethicone 20 mg) 1 fl. oz., Boudreaux's Butt Paste
Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
2019-03-20FDA-DrugGolean Detox USClass I
Golean DETOX capsules, 14 Net: 56 g, 14 packets containing 2 capsules per packet, 28-count capsules per box, MAT XI S.G Co., LTD, Head office: J29 Vo Thi Sau Street, Thong Nhat Ward, Bien Hoa City, Dong Nai Province, Viet Nam; Manufactory: 148/9 Tan Tien Ward, Bien Hoa City, Dong Nai Province, Viet Nam; Product distribution franshise by GoLean Detox Enterprise 002677155-A Malaysia, www.matxisg.com, UPC 8 938510 909013.
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the US market due to safety concerns. Phenolphthalein was once an ingredient used in over-the-counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the US. The presence of sibutramine and phenolphthalein in this product renders it an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall.
2019-03-20FDA-DrugMacleods Pharma Usa IncClass II
Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-130-07
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
2019-03-20FDA-DrugMacleods Pharma Usa IncClass II
Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Imachal Pradesh, India NDC 33342-129-07
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
2019-03-20FDA-DrugMacleods Pharma Usa IncClass II
Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, Rx Only, Manufactured for:Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured for: Macleods Pharmaceuticals Ltd. Baddi, Himchal Pradesh INDIA, NDC 33342-128-07
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
2019-03-20FDA-DrugRoberts Home Medical LLCClass II
Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home Medical, Inc. Germantown, MD. 20875
CGMP Deviations
2019-03-20FDA-DrugDr. Reddy's Laboratories, Inc.Class II
Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, Andhra Pradesh, INDIA, NDC 43598-259-40.
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
2019-03-20FDA-DrugLannett Company Inc.Class III
Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19154 NDC: 62175-271-37
Failed Dissolution Specifications
2019-03-20FDA-DrugAkorn, Inc.Class II
Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10.
Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point.
2019-03-20FDA-DrugBoehringer Ingelheim Pharmaceuticals, Inc.Class III
Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0190-61.
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
2019-03-20FDA-DrugAVKARE Inc.Class III
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Failed Dissolution Specifications
2019-03-20FDA-DrugKing Bio Inc.Class I
Dr. King's SafeCare Rx Breast Cyst & Discomforts High Potency Homeopathic Formula for Professional Use Only, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955000327, NDC 57955-0003-2
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
Dr. King's SafeCare Rx Aversion to Change High Potency Homeopathic Formula for Professional Use Only, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955280026, NDC 57955-2800-2
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
Dr. King's Natural Medicine Regional Allergies Hawaii U.S. Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955520620, NDC 57955-5206-2
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
Dr. King's Natural Medicine Leg Cramp & Spasm Relief Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955543527, NDC 57955-6035-2
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
Dr. King's Natural Medicine Good Mood Enhancer Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955515029, NDC 57955-8150-2
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
Dr. King's Natural Medicine Bug Away Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955507726, NDC 57955-5077-2
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
Dr. King's SafeCareRx CS-Lung High Potency Homeopathic Formula for Professional Use Only, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955022626, NDC 57955-0226-2
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
Dr. King's Natural Medicine Kids Aquaflora Candida Multi-Strain Formula, 118 mL (liquid), Manufactured by: King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, Imported by Ambiental Solutions, Inc. Vancouver, BC, V5Y 1E6, DIN-HM 80074869 UPC 357955181941
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
Dr. King's Bronchial Care, 59 mL (liquid/liquid), Manufactured by: King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 Imported by Ambiental Solutions, Inc. Vancouver, BC, V5Y 1E6, DIN-HM 80035774 UPC 357955180425
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
Dr. King's Advanced Arnica Super Arnica, 59 mL, Manufactured by: King Bio, Inc. 3 Westside Dr. Asheville, NC 28806 Imported by Ambiental Solutions, Inc. Vancouver, BC, V5Y 1E6, DIN-HM 800774304 UPC 357955181330
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
Dr. King's SafeCare Rx Hyperactive High Potency Homeopathic Formula, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955151029, NDC 57955-1511-2
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
Dr. King's SafeCare Rx Sinus Relief High Potency Homeopathic Formula, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955013426, NDC 57955-0134-2
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
Dr. King's SafeCare Rx Melancholic Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955201021, NDC 57955-2011-2
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
Dr. King's SafeCare Rx Aller-Detox: Outdoor Pollution Control Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955240426, NDC 57955-2404-2
Microbial contamination
2019-03-20FDA-DrugKing Bio Inc.Class I
Dr. King's SafeCare Rx Allergies Pacific U.S. Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955260820, NDC 57955-2717-2
Microbial contamination

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