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.

2018-09-26FDA-DrugTorrent Pharma Inc.Class II
Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. NDC: 13668-342-30
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
2018-09-26FDA-DrugBeaumont Bio-med, Inc.Class II
Arthritis Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7042-7
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
2018-09-26FDA-DrugBeaumont Bio-med, Inc.Class II
Colds & Flu Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7012-7
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
2018-09-26FDA-DrugBeaumont Bio-med, Inc.Class II
Allergy & Hay Fever Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7011-7
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
2018-09-26FDA-DrugBeaumont Bio-med, Inc.Class II
Muscle & Joint Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7041-7
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
2018-09-26FDA-DrugBeaumont Bio-med, Inc.Class II
Diarrhea Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7022-7
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
2018-09-26FDA-DrugBeaumont Bio-med, Inc.Class II
Sore Throat & Laryngitis Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7014-7
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
2018-09-26FDA-DrugBeaumont Bio-med, Inc.Class II
Sinus Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7013-7
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
2018-09-26FDA-DrugBeaumont Bio-med, Inc.Class II
Skin Irritation & Itch Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7002-7
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
2018-09-26FDA-DrugDr. Reddy's Laboratories, Inc.Class II
Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532 409 INDIA, NDC 55111-179-15, UPC 35511179153
Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
2018-09-26FDA-DrugBaxter Healthcare CorporationClass II
0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338-0049-31
cGMP Deviation
2018-09-26FDA-DrugQuVa Pharma, Inc.Class I
Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 08804, UPC 70092103417.
Subpotent Drug: Product may not have the active ingredient present in the bag.
2018-09-19FDA-DrugAccord Healthcare, Inc.Class I
Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703; Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, India; NDC 16729-182-01.
Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.
2018-09-19FDA-DrugHellolifeClass I
Respitrol, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-003-02
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
2018-09-19FDA-DrugHellolifeClass I
Thyroveev, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-025-02
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
2018-09-19FDA-DrugHellolifeClass I
Neuroveen, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-015-02
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
2018-09-19FDA-DrugHellolifeClass I
Compulsin, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-034-02
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
2018-09-19FDA-DrugSCA Pharmaceuticals, Inc.Class I
Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205, 877.550.5059, barcode 70004063032.
Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
2018-09-19FDA-DrugUnited Therapeutics Corp.Class III
Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) (NDC 66302-206-01) b) TD-300/A Replacement Device Kit Material Number RTP3099 RX Only. Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709
Defective Delivery System: Water ingress through the lower water cup sensor of the device.
2018-09-19FDA-DrugMylan Pharmaceuticals Inc.Class III
Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
2018-09-19FDA-DrugMylan Pharmaceuticals Inc.Class III
Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
2018-09-19FDA-DrugPar Pharmaceutical, Inc.Class III
Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11
Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
2018-09-19FDA-DrugPfizer Inc.Class III
Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
2018-09-12FDA-DrugAkorn, Inc.Class II
Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 30062. Mfg By: Swiss Caps AG, Kirchberg, Switzerland. NDC: 61748-025-01
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
2018-09-12FDA-DrugAvkare IncorporatedClass II
AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-888-90
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
2018-09-12FDA-DrugAvkare IncorporatedClass II
AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-886-90
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
2018-09-12FDA-DrugAvkare IncorporatedClass II
AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-887-90
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
2018-09-12FDA-DrugAvkare IncorporatedClass II
AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-885-90
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
2018-09-12FDA-DrugAvkare IncorporatedClass II
AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-884-90
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
2018-09-12FDA-DrugMckesson CorporationClass II
Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in boxes of 20 cups), Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977 Dist. By: McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, NC 28027, NDC 63739-549-51
Supterpotent Drug

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