The Recall Desk

Archive

June 2021 recalls

771 recalls were announced in June 2021.

What the numbers show

Critical
10
Severe
119
High
371
Moderate
260
Low
11

Of the 771 recalls this month scored against our rubric, 1% are Critical, 15% are Severe.

601–700 of 771

  • ModerateFDA (Drugs)·D-0507-2021·2021-06-02

    Cardinal Health Recalls NOHIST DM Due to Temperature Excursions

    Cardinal Health is recalling NOHIST DM antihistamine and decongestant liquid due to intermittent temperature excursions during storage.

    Product
    NOHIST DM — NOHIST DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0586-2021·2021-06-02

    Cardinal Health Recalls Tramadol Hydrochloride Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling 86 bottles of Tramadol Hydrochloride 100mg tablets due to intermittent exposure to temperature excursions during storage.

    Product
    TRAMADOL HYDROCHLORIDE TABLETS USP 100MG, 100-count bottle, Rx Only, Manufactured by: Rubicon Research :Private Limited, Ambernath, Dist. Thane, 421506 India, NDC: 52817-0196-10
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0449-2021·2021-06-02

    Cardinal Health Recalls Belbuca Due to Temperature Excursions

    Cardinal Health is recalling 47 cartons of Belbuca (buprenorphine hydrochloride) buccal film due to intermittent exposure to temperature excursions during storage.

    Product
    BELBUCA — BELBUCA (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0532-2021·2021-06-02

    Cardinal Health Recalls Vitamin D3 Supplements Due to Temperature Excursions

    Cardinal Health Inc. is recalling 205 bottles of Vitamin D3 Cholecalciferol 50,000 IU dietary supplements due to intermittent exposure to temperature excursions during storage.

    Product
    Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 12 Capsules NDC 75834-020-12 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 USA
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0435-2021·2021-06-02

    Cardinal Health Recalls XIGDUO Tablets Due to Temperature Excursions

    Cardinal Health is recalling 664 bottles of XIGDUO tablets because of intermittent temperature exposure during storage. The affected products were distributed in Florida, Georgia, and South Carolina.

    Product
    XIGDUO — XIGDUO (DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1678-2021·2021-06-02

    Nobel Biocare Procera Implant Crown Recall for Manufacturing Defects

    Nobel Biocare Procera LLC is recalling seven implant crown units because they were not manufactured to specification. The recall covers distribution in the US and several international countries.

    Product
    NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77352
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0569-2021·2021-06-02

    Cardinal Health Recalls COREG CR Capsules Due to Temperature Excursions

    Cardinal Health is recalling 133 bottles of COREG CR 80 mg capsules due to intermittent temperature exposure during storage.

    Product
    COREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bottle, Rx Only,/UPC 57664066683
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0418-2021·2021-06-02

    Cardinal Health Recalls Namzaric Due to Temperature Excursions

    Cardinal Health is recalling 659 bottles of Namzaric capsules due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    NAMZARIC — NAMZARIC (MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0557-2021·2021-06-02

    Cardinal Health Recalls LEVOXYL Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling 13 bottles of LEVOXYL tablets due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0456-2021·2021-06-02

    Cardinal Health Recalls Synjardy Tablets Due to Temperature Excursions

    Cardinal Health is recalling 284 bottles of Synjardy tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    Synjardy (empagliflozin and metformin hydrochloride) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0168-69 Distributed by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0428-2021·2021-06-02

    Cardinal Health Recalls Timolol Maleate Ophthalmic Solution Due to Temperature Excursions

    Cardinal Health Inc. is recalling 31 droptainers of Timolol Maleate Ophthalmic Solution 0.5% due to intermittent exposure to temperature excursions during storage.

    Product
    Timolol Maleate Ophthalmic Solution, USP 0.5% 2.5 mL Sterile For Topical Application In The Eye Rx Only NDC 60505-1005-4 Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0424-2021·2021-06-02

    Cardinal Health Recalls Erythromycin Tablets Due to Temperature Excursions

    Cardinal Health is recalling Erythromycin Tablets 250mg due to intermittent temperature excursions during storage. The recall affects 135 cartons distributed in Florida, Georgia, and South Carolina.

    Product
    ERYTHROMYCIN TABLETS, USP 250MG 30; NDC/UPC 69238-1484-3; RX; TABLETS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0455-2021·2021-06-02

    Cardinal Health Recalls Glyxambi Tablets Due to Temperature Excursions

    Cardinal Health is recalling 592 bottles of Glyxambi tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    GLYXAMBI — GLYXAMBI (EMPAGLIFLOZIN AND LINAGLIPTIN)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0546-2021·2021-06-02

    Cardinal Health Recalls Fexofenadine Tablets Due to Temperature Excursions

    Cardinal Health is recalling 321 bottles of Fexofenadine Hydrochloride 180 mg tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine Non-Drowsy 100 Tablets 180 mg Each NDC 45802-571-78 Distributed By Perrigo Allegan, MI 49010
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Food)·F-0564-2021·2021-06-02

    Brew Dr. Uplift Drink Recalled Due to Yeast Presence

    Brew Dr. Uplift Blood Orange Lemon drink is being recalled because yeast was found in the shelf-stable cans.

    Product
    Brew Dr. Uplift Blood Orange Lemon, Yerba Mate *Guayusa * Green Tea, Natural Caffeine With Probiotics. 12/16 oz. aluminum cans per cardboard flat. UPC 8 57161 00870 9. The label is read in parts: "***BLOOD ORANGE LEMON *** YERBA MATE * GUAYUSA * GREEN TEA***BREW DR. UPLIFT…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0531-2021·2021-06-02

    Cardinal Health Recalls Vitamin D3 Supplements Due to Temperature Excursions

    Cardinal Health Inc. is recalling 523 bottles of Vitamin D3 Cholecalciferol 50,000 IU dietary supplements due to intermittent exposure to temperature excursions during storage.

    Product
    Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 100 Capsules NDC 75834-020-01 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0481-2021·2021-06-02

    Cardinal Health Recalls Trelegy Ellipta Due to Temperature Excursions

    Cardinal Health Inc. is recalling 4,065 cartons of Trelegy Ellipta inhalers due to intermittent exposure to temperature excursions during storage.

    Product
    TRELEGY ELLIPTA — TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0534-2021·2021-06-02

    Cardinal Health Recalls Ilevro Ophthalmic Suspension Due to Temperature Excursions

    Cardinal Health Inc. is recalling Ilevro (nepafenac ophthalmic suspension) 0.3% due to intermittent exposure to temperature excursions during storage.

    Product
    Ilevro (nepafenac ophthalmic suspension) 0.3% 3 mL Sterile Rx Only NDC 0065-1750-14 Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0508-2021·2021-06-02

    Cardinal Health Recalls TRI-LO-MARZIA Due to Temperature Excursions

    Cardinal Health is recalling 60 cartons of TRI-LO-MARZIA oral contraceptives distributed in Florida, Georgia, and South Carolina due to intermittent temperature excursions during storage.

    Product
    TRI-LO-MARZIA — TRI-LO-MARZIA (NORGESTIMATE AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0470-2021·2021-06-02

    Cardinal Health Recalls Phenobarbital Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling Phenobarbital Tablets, USP 32.4 mg due to intermittent exposure to temperature excursions during storage.

    Product
    Phenobarbital Tablets, USP 32.4 mg 100 tablets Rx only NdC 13517-111-01 Manufactured for: e5 Pharma, LLC., Boca Raton, FL 33432
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0561-2021·2021-06-02

    Cardinal Health Recalls Budesonide and Formoterol Inhalers for Temperature Excursions

    Cardinal Health Inc. is recalling 905 units of Budesonide and Formoterol Fumarate Dihydrate inhalers due to intermittent temperature exposure during storage.

    Product
    BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE — BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE (BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0477-2021·2021-06-02

    Cardinal Health Recalls Flovent Diskus Inhalers Due to Temperature Excursions

    Cardinal Health Inc. is recalling 237 units of Flovent Diskus 100mcg inhalers due to intermittent temperature excursions during storage.

    Product
    FLOVENT DISKUS 100MCG 60; NDC/UPC 173060202; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0596-2021·2021-06-02

    Cardinal Health Recalls Cough Syrup Due to Temperature Excursions

    Cardinal Health Inc. is recalling 15 bottles of a cough syrup due to intermittent temperature excursions during storage.

    Product
    Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup Net: 1 Pint (473 mL) Bulk Container-Not for Household Use Rx Only NDC 60432-275-16 Distributed By: Wockhardt USA, LLC Parsippany, NJ 07054
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0518-2021·2021-06-02

    Cardinal Health Recalls Rugby Benzoyl Peroxide Wash Due to Temperature Excursions

    Cardinal Health is recalling Rugby Benzoyl Peroxide Wash 5% due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    RUGBY BENZOYL PEROXIDE WASH — RUGBY BENZOYL PEROXIDE WASH (BENZOYL PEROXIDE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0562-2021·2021-06-02

    Cardinal Health Recalls Medroxyprogesterone Acetate Syringes Due to Temperature Excursions

    Cardinal Health is recalling 286 prefilled syringes of medroxyprogesterone acetate due to intermittent temperature excursions during storage.

    Product
    Medroxyprogesterone acetate injectable suspension, USP 150 mg per mL 1 mL Prefilled Syringe Rx only NDC 59762-4538-2 Distributed by: Greenstone, LLC. Peapack, NJ 07977
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Food)·F-0563-2021·2021-06-02

    Brew Dr. Uplift Blueberry Raspberry Yerba Mate Recalled for Yeast

    Brew Dr. Uplift Blueberry Raspberry Yerba Mate is being recalled because yeast was found in the shelf-stable cans.

    Product
    Brew Dr. Uplift Blueberry Raspberry Yerba Mate Guayusa, Green Tea, Natural Caffeine With Probiotics. 12/16 oz. aluminum cans per cardboard flat. UPC 8 57161 00867 9. The label is read in parts: "***BLUEBERRY RASPBERRY ***YERBA MATE * GUAYUSA * GREEN TEA***BREW DR UPLIFT ***…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0537-2021·2021-06-02

    Cardinal Health Recalls Benztropine Mesylate Tablets Due to Storage Temperature Excursions

    Cardinal Health is recalling Benztropine Mesylate Tablets due to intermittent exposure to temperature excursions during storage. The affected products were distributed to Florida, Georgia, and South Carolina.

    Product
    Benztropine Mesylate Tablets, USP in all pack sizes, styles and strengths Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1686-2021·2021-06-02

    CooperSurgical Recalls Incorrectly Packaged Ultem Koh Cup Vaginal Delineators

    CooperSurgical is recalling specific Koh Cup vaginal delineators that were incorrectly packaged with a 3.5cm cup instead of the required 3.0cm model.

    Product
    The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0541-2021·2021-06-02

    Cardinal Health Recalls Risperidone Solution Due to Temperature Excursions

    Cardinal Health Inc. is recalling 39 bottles of Risperidone 1mg/mL solution due to intermittent temperature excursions during storage.

    Product
    RISPERIDONE 1MG/ML 30ML; NDC/UPC 50458059601; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0445-2021·2021-06-02

    Cardinal Health Recalls MURO-128 Eye Drops Due to Temperature Excursions

    Cardinal Health is recalling MURO-128 2% eye drops due to intermittent temperature excursions during storage. The affected units were distributed in Florida, Georgia, and South Carolina.

    Product
    MURO-128 2% 15ML OPTH; NDC/UPC 324208276150; OTC; DROPS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0452-2021·2021-06-02

    Cardinal Health Recalls CATAPRES-TTS-2 Patches Due to Temperature Excursions

    Cardinal Health is recalling CATAPRES-TTS-2 adhesive patches due to intermittent exposure to temperature excursions during storage. The affected units were distributed in Florida, Georgia, and South Carolina.

    Product
    CATAPRES-TTS-2 1X4; NDC/UPC 597003234; RX; ADHESIVE PATCHES
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0401-2021·2021-06-02

    Cardinal Health Recalls Niacin Tablets Due to Temperature Excursions

    Cardinal Health is recalling Niacin 250mg tablets due to intermittent temperature excursions during storage. The recall affects 4 bottles distributed in Florida, Georgia, and South Carolina.

    Product
    NIACIN 250MG 110; NDC/UPC 740985228494; OTC; TABLETS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0571-2021·2021-06-02

    Cardinal Health Recalls Colcrys Tablets Due to Temperature Excursions

    Cardinal Health is recalling 160 bottles of Colcrys tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    Colcrys (colchicine, USP) tablets 0.6 mg 30 tablets Rx only Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015,NDC 64764-119-07
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0505-2021·2021-06-02

    Cardinal Health Recalls Siladryl Liquid Due to Temperature Excursions

    Cardinal Health is recalling 78 bottles of Siladryl 12.5/5ml liquid because of intermittent temperature excursions during storage.

    Product
    SILADRYL 12.5/5ML 118ML SF AF; NDC/UPC 354838135404; OTC; LIQUID
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0555-2021·2021-06-02

    Cardinal Health Recalls Chantix Tablets Due to Temperature Excursions

    Cardinal Health is recalling 848 bottles of Chantix (varenicline tartrate) tablets due to intermittent exposure to temperature excursions during storage.

    Product
    CHANTIX — CHANTIX (VARENICLINE TARTRATE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0493-2021·2021-06-02

    Cardinal Health Recalls Leucovorin Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling Leucovorin 15mg tablets due to intermittent temperature excursions during storage. The affected products were distributed in Florida, Georgia, and South Carolina.

    Product
    LEUCOVORIN 15MG 24; NDC/UPC 54449810; RX; TABLETS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0521-2021·2021-06-02

    Cardinal Health Recalls Pedia-Lax Enemas Due to Temperature Excursions

    Cardinal Health is recalling 147 units of Pedia-Lax 66ml enemas due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    PEDIA-LAX 66ML; NDC/UPC 301320202205; OTC; ENEMA
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0560-2021·2021-06-02

    Cardinal Health Recalls Intrarosa Prasterone Vaginal Inserts Due to Temperature Excursions

    Cardinal Health Inc. is recalling 205 cartons of Intrarosa Prasterone Vaginal Inserts due to intermittent temperature excursions during storage.

    Product
    Intrarosa Prasterone Vaginal Inserts 6.5 mg 28 inserts/applicators Rx Only Manufactured for: Ednoceutics, Inc. Quebec City, Canada, G1V 4M7 Distributed by: AMAG Pharmaceuticals, Inc. Waltam, MA 02451, NDC 64011-601-28
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0443-2021·2021-06-02

    Cardinal Health Recalls Lotemax Eye Gel Due to Temperature Excursions

    Cardinal Health is recalling 463 boxes of Lotemax eye gel distributed in Florida, Georgia, and South Carolina due to intermittent temperature excursions during storage.

    Product
    LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM; NDC/UPC 24208-0507-07; RX; GEL
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0466-2021·2021-06-02

    Cardinal Health Recalls Prilosec Due to Temperature Excursions

    Cardinal Health is recalling Prilosec (Omeprazole Magnesium) oral suspension packets due to intermittent temperature excursions during storage.

    Product
    PRILOSEC — PRILOSEC (OMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0594-2021·2021-06-02

    Cardinal Health Recalls Corgard Tablets Due to Temperature Excursions

    Cardinal Health is recalling Corgard (nadolol) 40 mg tablets due to intermittent exposure to temperature excursions during storage.

    Product
    Corgard (nadolol tablets, USP) 40 mg 100 Tablets Rx only NDC 27505-101-01 Distributed by US WorldMeds, LLC, Louisville, KY 40241
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0579-2021·2021-06-02

    Cardinal Health Recalls Balziva Due to Temperature Excursions

    Cardinal Health Inc. is recalling 23 bottles of Balziva (norethindrone and ethinyl estradiol) due to intermittent exposure to temperature excursions during storage.

    Product
    BALZIVA — BALZIVA (NORETHINDRONE AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0444-2021·2021-06-02

    Cardinal Health Recalls Benzefoam Emollient Foam Due to Temperature Excursions

    Cardinal Health Inc. is recalling Benzefoam Emollient Foam due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    BENZEFOAM EMOLLIENT FOAM BENZOYL PEROXIDE 5.3% 100GM TOP EMOL NDC 187-0194--10; OTC; FOAMS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0411-2021·2021-06-02

    Cardinal Health Recalls COSOPT Eye Drops Due to Temperature Excursions

    Cardinal Health Inc. is recalling 12 bottles of COSOPT ophthalmic solution due to intermittent temperature excursions during storage.

    Product
    COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolamide Hydrochloride 22.3 mg/mL Timolol Maleate 6.8 mg/mL) 10ML Ocumeter Plus Ophthalmic Dispenser Sterile Ophthlamic Solution Rx only NDC/UPC 174780-605-10 Distributed by: Akorn, Inc. Lake Forest, IL…
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0519-2021·2021-06-02

    Cardinal Health Recalls Vitamin D3 Tablets Due to Temperature Excursions

    Cardinal Health is recalling Vitamin D3 50mcg tablets due to intermittent exposure to temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    VITAMIN D3 50MCG 100 CALC; NDC/UPC 880681170007; OTC; TABLETS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0564-2021·2021-06-02

    Cardinal Health Recalls Cefazolin Injection Due to Temperature Excursions

    Cardinal Health Inc. is recalling Cefazolin for Injection due to intermittent exposure to temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    CEFAZOLIN — CEFAZOLIN (CEFAZOLIN)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Food)·F-0565-2021·2021-06-02

    Brew Dr. Uplift Mango Passionfruit Recalled for Yeast Contamination

    Brew Dr. Uplift Mango Passionfruit drinks are being recalled because yeast was found in the product. Consumers should stop drinking the affected cans.

    Product
    Brew Dr. Uplift Mango Passionfruit, Yerba Mate *Guayusa * Green Tea, Natural Caffeine With Probiotics. 12/16 oz. aluminum cans per cardboard flat. UPC 8 57161 00871 6. The label is read in parts: "***MANGO PASSIONFRUIT *** YERBA MATE * GUAYUSA * GREEN TEA *** BREW DR. UPLIFT…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0469-2021·2021-06-02

    Cardinal Health Recalls Pregabalin Capsules Due to Temperature Excursions

    Cardinal Health Inc. is recalling Pregabalin 300mg capsules due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    PREGABALIN — PREGABALIN (PREGABALIN)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0598-2021·2021-06-02

    Native Fluoride Toothpaste Recalled for Incorrect Fluoride-Free Labeling

    Accupac, Inc. is recalling Native Fluoride Toothpaste for Sensitive Teeth because the primary label may incorrectly state 'Fluoride-Free' instead of 'With Fluoride.'

    Product
    Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium nitrate, 0.243% sodium fluoride (0.14% w/v fluoride ion), Net Wt. 4.1 oz.,116 g, , Distr by Native, San Francisco, CA 94111 NDC: 69423-903-41, UPC 0 37000 28803 9
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0530-2021·2021-06-02

    Cardinal Health Recalls Vitamin D3 Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling 47 bottles of NAT B VIT D3 2000U tablets due to intermittent exposure to temperature excursions during storage.

    Product
    NAT B VIT D3 2000U 100; NDC/UPC 079854041125; OTC; TABLETS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1688-2021·2021-06-02

    Ortho VITROS CoV2 Ag Calibrator Recalled for Calibration Failures

    Ortho-Clinical Diagnostics is recalling 74 units of VITROS CoV2 Ag calibrator (Lot 0020) due to potential unexpected calibration failures.

    Product
    VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDCs formulation of VTM.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0426-2021·2021-06-02

    Cardinal Health Recalls Enoxaparin Syringes Due to Temperature Excursions

    Cardinal Health is recalling 64 boxes of Enoxaparin Dofium Injection 150mg/1ml syringes due to intermittent temperature excursions during storage.

    Product
    ENOXAPARIN DOFIUM INJRVYION, UPD 150MG/1ML 10X1ML SINGLE DOSE SYRINGES; NDC/UPC 60505-0798-4; RX; SYRINGES
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0458-2021·2021-06-02

    Cardinal Health Recalls Synjardy Tablets Due to Temperature Excursions

    Cardinal Health is recalling 269 bottles of Synjardy XR tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    SYNJARDY — SYNJARDY (EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0558-2021·2021-06-02

    Cardinal Health Recalls Promethazine Oral Solution Due to Temperature Excursions

    Cardinal Health Inc. is recalling Promethazine Plain Oral Solution due to intermittent temperature excursions during storage.

    Product
    PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS), Rx Only, NDC 0211-0927-16
    Category
    Drug
    Distribution
    3 states

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