The Recall Desk

Archive

June 2021 recalls

771 recalls were announced in June 2021.

What the numbers show

Critical
10
Severe
106
High
384
Moderate
260
Low
11

Of the 771 recalls this month scored against our rubric, 1% are Critical, 14% are Severe.

601–700 of 771

  • ModerateFDA (Drugs)·D-0461-2021·2021-06-02

    Cardinal Health Recalls Valsartan Tablets Due to Temperature Excursions

    Cardinal Health is recalling Valsartan 40 mg tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0487-2021·2021-06-02

    Cardinal Health Recalls Hydrocortisone Ointment Due to Temperature Excursions

    Cardinal Health Inc. is recalling 23 tubes of Hydrocortisone Ointment USP 1% due to intermittent exposure to temperature excursions during storage.

    Product
    Hydrocortisone Ointment USP 1% Maximum Strength Net Wt. 1 oz (28 g) NDC 0472-0345-56 Manufactured by: Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28902
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0529-2021·2021-06-02

    Cardinal Health Recalls Proctofoam Aerosol Due to Temperature Excursions

    Cardinal Health is recalling 834 containers of Proctofoam HC aerosol due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    PROCTOFOAM — PROCTOFOAM (PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE)
    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-0585-2021·2021-06-02

    Cardinal Health Recalls Folivane-Plus Capsules Due to Temperature Excursions

    Cardinal Health is recalling 80 bottles of Folivane-Plus capsules because they were intermittently exposed to temperature excursions during storage.

    Product
    Folivane-Plus with Ascorbic Acid Precursors Iron/Folic Acid/Vitamin Supplement Capsules 90 Capsules Rx Only NDC 13811-539-90 Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872
    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-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-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-0409-2021·2021-06-02

    Cardinal Health Recalls Lidocaine HCL Visc 2% Due to Temperature Excursions

    Cardinal Health Inc. is recalling 240 bottles of Lidocaine HCL Visc 2% 100ml due to intermittent temperature excursions during storage.

    Product
    LIDOCAINE HCL VISC 2% 100ML; NDC/UPC 50383077504; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0496-2021·2021-06-02

    Cardinal Health Recalls Enbrace HR Prenatal Vitamins Due to Temperature Excursions

    Cardinal Health is recalling 11 bottles of Enbrace HR prenatal vitamins due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    ENBRACE HR — ENBRACE HR (LEVOMEFOLATE MAGNESIUM, LEUCOVORIN, FOLIC ACID, FERROUS CYSTEINE GLYCINATE, MAGNESIUM ASCORBATE, ZINC ASCORBATE, COCARBOXYLASE, FLAVIN ADENINE DINUCLEOTIDE, NADH, PYRIDOXAL PHOSPHATE ANHYDROUS, COBAMAMIDE, BETAINE, MAGNESIUM L-THREONATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, AND PHOSPHATIDYL SERINE)
    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 (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 *** N
    Category
    Food
    Distribution
    Distributed nationwide
  • 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-0432-2021·2021-06-02

    Cardinal Health Recalls Gemcitabine Injection Due to Temperature Excursions

    Cardinal Health is recalling Gemcitabine Injection 200mg/5.26ml vials due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL
    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-0563-2021·2021-06-02

    Cardinal Health Recalls Medroxyprogesterone Acetate Injectable Due to Temperature Excursions

    Cardinal Health Inc. is recalling 148 syringes of medroxyprogesterone acetate injectable suspension due to intermittent exposure to temperature excursions during storage.

    Product
    medroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-4538-02
    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 (Drugs)·D-0552-2021·2021-06-02

    Cardinal Health Recalls LYRICA Capsules Due to Temperature Excursions

    Cardinal Health is recalling 49 bottles of LYRICA (pregabalin) 200mg capsules due to intermittent exposure to temperature excursions during storage.

    Product
    LYRICA (pregabalin) capsules, 200mg 90-count bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, MADE IN SINGAPORE
    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-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-0500-2021·2021-06-02

    Cardinal Health Recalls Livalo Tablets Due to Temperature Excursions

    Cardinal Health is recalling 453 bottles of Livalo (pitavastatin calcium) 2 mg tablets due to intermittent exposure to temperature excursions during storage.

    Product
    LIVALO — LIVALO (PITAVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0405-2021·2021-06-02

    Cardinal Health Recalls Synthroid Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling 123 bottles of Synthroid (levothyroxine sodium) tablets distributed in Florida, Georgia, and South Carolina due to intermittent temperature excursions during storage.

    Product
    Synthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles and concentrations Rx only Abbott Laboratories North Chicago, IL
    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-0517-2021·2021-06-02

    Cardinal Health Recalls Dibucaine Topical Anesthetic Due to Temperature Excursions

    Cardinal Health Inc. is recalling 701 cartons of Dibucaine Topical Anesthetic 1% Hemorrhoidal Ointment due to intermittent temperature excursions during storage.

    Product
    DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL — DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL (DIBUCAINE)
    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-0475-2021·2021-06-02

    Cardinal Health Recalls Prenatal Tablets Due to Temperature Excursions

    Cardinal Health is recalling 41 bottles of prenatal tablets due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    Prenatal Tablets Gluten Free Multivitamin/ Multimineral Dietary Supplement for Pregnant and Lactating Women UD 100 Tablets (10x10) NDC 77333-715-10 GenDose Pharmaceuticals
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0442-2021·2021-06-02

    Cardinal Health Recalls Nuedexta Due to Temperature Excursions

    Cardinal Health is recalling 255 bottles of Nuedexta capsules due to intermittent exposure to temperature excursions during storage.

    Product
    NUEDEXTA — NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1675-2021·2021-06-02

    Roche Recalls Iron Gen 2 Reagent Cassettes Due to Discrepant Results

    Roche Diagnostics is recalling 20,468 Iron Gen 2 reagent cassettes because they may produce discrepant elevated results on specific analyzers.

    Product
    IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas Integra systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Devices)·Z-1681-2021·2021-06-02

    Nobel Biocare Procera LLC Recalls Implant Crowns Not Manufactured to Specification

    Nobel Biocare Procera LLC is recalling specific implant crowns because they were not manufactured to specification. The recall affects units distributed in the US and several international countries.

    Product
    NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 - 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: 77387
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0460-2021·2021-06-02

    Cardinal Health Recalls Pravachol 40mg Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling Pravachol 40mg tablets due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    PRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETS
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0522-2021·2021-06-02

    Cardinal Health Recalls Belsomra Tablets Due to Temperature Excursions

    Cardinal Health is recalling 119 cartons of Belsomra (suvorexant) 10 mg tablets due to intermittent temperature excursions during storage.

    Product
    Belsomra (suvorexant) tablets 10 mg Each tablet contains 10 mg suvorexant. This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets Rx only NDC 00006-0033-30 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0539-2021·2021-06-02

    Cardinal Health Recalls Zolpidem Tablets Due to Temperature Excursions

    Cardinal Health is recalling 55 boxes of Zolpidem Tartrate Sublingual Tablets 3.5 mg due to intermittent exposure to temperature excursions during storage.

    Product
    ZOLPIDEM TARTRATE SUBLINGUAL TABLET 3.5 MG 30 UNIT DOSE POUCHES; NDC/UPC 49884089911; RX; EACH POUCH CONTAINS ONE SUBLINGUAL TABLET
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0421-2021·2021-06-02

    Cardinal Health Recalls Nitrofurantoin Capsules Due to Storage Temperature Excursions

    Cardinal Health Inc. is recalling 15 bottles of Nitrofurantoin Macrocrystals Capsules 25 mg due to intermittent exposure to temperature excursions during storage.

    Product
    Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only NDC 47781-306-01 Manufactured by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 Distributed by: Alvogen, Inc. Parsippany, NJ 07054 U.S.A.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0587-2021·2021-06-02

    Cardinal Health Recalls Restora Omega-3 Supplement Due to Temperature Excursions

    Cardinal Health Inc. is recalling 31 cartons of Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules due to intermittent exposure to temperature excursions during storage.

    Product
    Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 1 A Day Nutritional Supplement NDC 52747-200-30 Marketed by US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0480-2021·2021-06-02

    Cardinal Health Recalls Arnuity Ellipta Due to Temperature Excursions

    Cardinal Health is recalling 353 Arnuity Ellipta inhalers distributed in Florida, Georgia, and South Carolina due to intermittent temperature exposure during storage.

    Product
    ARNUITY ELLIPTA — ARNUITY ELLIPTA (FLUTICASONE FUROATE)
    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-0471-2021·2021-06-02

    Cardinal Health Recalls Ivermectin Tablets Due to Temperature Excursions

    Cardinal Health is recalling 504 cartons of Ivermectin Tablets USP 3 mg due to intermittent exposure to temperature excursions during storage.

    Product
    Ivermectin Tablets USP 3 mg 20 Tablets (2 Foil Strips of 10 tablets each) Rx Only NDC 4799-806-01 Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054 877-381-3336
    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-0499-2021·2021-06-02

    Cardinal Health Recalls Auryxia Tablets Due to Temperature Excursions

    Cardinal Health is recalling 136 bottles of Auryxia (ferric citrate) 210 mg tablets due to intermittent exposure to temperature excursions during storage.

    Product
    AURYXIA — AURYXIA (FERRIC CITRATE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0543-2021·2021-06-02

    Cardinal Health Recalls Benzoyl Peroxide Acne Wash Due to Temperature Excursions

    Cardinal Health is recalling 31 bottles of Benzoyl Peroxide 10% Acne Medication Wash due to intermittent temperature exposure during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    Benzoyl Peroxide 10% Acne Medication Wash Net Wt 5 oz (142 g) Distributed By Perrigo Allegan, MI 49010, NDC 45802-318-01
    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-0540-2021·2021-06-02

    Cardinal Health Recalls HySept Solution Due to Temperature Excursions

    Cardinal Health is recalling 236 bottles of HySept Solution 0.25% Sodium Hypochlorite due to intermittent temperature excursions during storage.

    Product
    HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.) NDC 39328-063-25 Manufactured in USA Patrin Pharma, Skokie, IL 60076
    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-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-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-0535-2021·2021-06-02

    Cardinal Health Recalls Ciprodex Eye Drops Due to Temperature Excursions

    Cardinal Health is recalling Ciprodex eye drops due to intermittent temperature excursions during storage. The affected product was distributed in Florida, Georgia, and South Carolina.

    Product
    CIPRODEX (CIPROFLOXACIN 0.3 AND DEXAMETHASONE 0.1%) 7.5ML; NDC/UPC 0078-0799-75; RX; DROPS
    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-0457-2021·2021-06-02

    Cardinal Health Recalls Jentadueto XR Due to Temperature Excursions

    Cardinal Health Inc. is recalling 52 bottles of Jentadueto XR tablets due to intermittent exposure to temperature excursions during storage.

    Product
    JENTADUETO XR — JENTADUETO XR (LINAGLIPTIN AND METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0497-2021·2021-06-02

    Cardinal Health Recalls Tylenol Acetaminophen Liquid Gels Due to Temperature Excursions

    Cardinal Health Inc. is recalling 37 bottles of Tylenol Acetaminophen Liquid Gels because of intermittent temperature exposure during storage.

    Product
    Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain Reliever Fever Reducer 20 Liquid Gels 325 mg each NDC 50580-487-20
    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-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 (Drugs)·D-0414-2021·2021-06-02

    Cardinal Health Recalls Vaniqa Cream Due to Temperature Excursions

    Cardinal Health is recalling 72 tubes of Vaniqa cream distributed in Florida, Georgia, and South Carolina due to intermittent temperature excursions during storage.

    Product
    Vaniqa (eflornithine hydrochloride) Cream, 13.9% For Topical Use Only Net wt. 1.59 oz (45 g) Rx only NDC 0023-4857-45 Manufactured for Allegan, Inc. Irvine, CA 92612
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0503-2021·2021-06-02

    Cardinal Health Recalls Infants Vitamin D Drops Due to Temperature Excursions

    Cardinal Health is recalling 422 bottles of Infants Aqueous Vitamin D Oral Drops due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL (1 2/3 fl oz) Manufactrued by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 10977 USA
    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-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 (Devices)·Z-1674-2021·2021-06-02

    Siemens Centaur Syphilis Assay Recalled for Potential Carryover Interference

    Siemens Healthcare Diagnostics is recalling the Centaur Syphilis Assay-SYP Kit due to potential carryover into other assays on specific systems.

    Product
    Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in human serum or plasma using the ADVIA Centaur XP/XPT System and ADVIA Centaur CP Systems, SMN:10492493
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0448-2021·2021-06-02

    Cardinal Health Recalls Belbuca Due to Temperature Excursions

    Cardinal Health is recalling 96 cartons of Belbuca buccal film due to intermittent exposure to temperature excursions during storage.

    Product
    BELBUCA — BELBUCA (BUPRENORPHINE HYDROCHLORIDE)
    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 (Drugs)·D-0410-2021·2021-06-02

    Cardinal Health Recalls Atropine Sulfate Ophthalmic Solution Due to Temperature Excursions

    Cardinal Health Inc. is recalling 424 bottles of Atropine Sulfate Ophthalmic Solution 1% due to intermittent temperature excursions during storage.

    Product
    Atropine Sulfate Ophthalmic Solution, USP 1% For Topical Application To The Eye Sterile 5 mL Rx only NDC 17478-215-05 Manufactured by: Akorn, Inc.
    Category
    Drug
    Distribution
    3 states

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