Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-09-19FDA-DrugHellolifeClass IThyroveev, 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 INeuroveen, 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 ICompulsin, 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 IFurosemide 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 IIITyvaso 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 IIIDiltiazem 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 IIIDiltiazem 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 IIIPramipexole 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 IIIArgatroban 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 IIEthosuximide 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 IIAvKARE 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 IIAvKARE 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 IIAvKARE 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 IIAvKARE 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 IIAvKARE 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 IIMegestrol 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
- 2018-09-05FDA-DrugValidus Pharmaceuticals, Inc.Class IIIRocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 USA, NDC 30698-911-15
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
- 2018-09-05FDA-DrugValidus Pharmaceuticals, Inc.Class IIICalcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
- 2018-09-05FDA-DrugPfizer Global SupplyClass IIChildren s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml) bottle, Pfizer, Madison, NJ 07940 USA, NDC 0573-0207-30, UPC 3-0573-0207-30-0
Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.
- 2018-09-05FDA-DrugAkorn, Inc.Class IIIAzelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-718-10
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
- 2018-09-05FDA-DrugAuro Pharmacies, Inc.Class IIMethyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- 2018-09-05FDA-DrugAuro Pharmacies, Inc.Class IIFolic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- 2018-09-05FDA-DrugAuro Pharmacies, Inc.Class IITestosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- 2018-09-05FDA-DrugAuro Pharmacies, Inc.Class IITestosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 mL and 8 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- 2018-09-05FDA-DrugAuro Pharmacies, Inc.Class IITestosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- 2018-09-05FDA-DrugAuro Pharmacies, Inc.Class IIMethyl-Cobalamin injectable, 10 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- 2018-09-05FDA-DrugAuro Pharmacies, Inc.Class IIMethyl-Cobalamin injectable, 5 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- 2018-09-05FDA-DrugAuro Pharmacies, Inc.Class IIMethyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multiple Dose vials, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- 2018-09-05FDA-DrugAuro Pharmacies, Inc.Class IIGlutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- 2018-09-05FDA-DrugAuro Pharmacies, Inc.Class IIDexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
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