June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Collagenase Santyl Ointment 250 units/g 30 grams Rx Only Marketed by Smith & Nephew, Inc., Fort Worth, TX 76107, NDC 504
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Tuberculin Purified Protein Derivative (Mantous) TUBERSOL, Stabilized Solution 5 US Units, Rx Only Sanofi Pasteur Limite
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls HYDROCORTISONE 1% 30gm cream
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Cefazolin for Injection, USP 1 gram per vial Rx Only Single-use Vial Sterile Manufactured in Austria by Sandoz GmbH for
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls medroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Only, Distributed by: Greenstone LLC, Peapack,
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Medroxyprogesterone acetate injectable suspension, USP 150 mg per mL 1 mL Prefilled Syringe Rx only NDC 59762-4538-2 Dis
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonide 80 mcg/formoterol fumarate dihydrate 4
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Intrarosa Prasterone Vaginal Inserts 6.5 mg 28 inserts/applicators Rx Only Manufactured for: Ednoceutics, Inc. Quebec Ci
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Nature's Truth Absorbable Calcium 1200 mg plus D3 5000 IU 120 Softgels Dietary Supplements Carefully Designed and Distri
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS), Rx Only, NDC 02
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls LEVOXYL Tablets, USD, 150MCG, 100-count bottle, Rx Only, Distributed by Pfizer Inc., New York, NY 10017, MADE IN AUSTRIA
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Chantix (varenicline) Tablets Starting Pack Contains: 1 Starting Week (0.5 mgx11 tablets) 3 Continuing Weeks (1 mgx42 ta
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only ; Rx only D
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only NDC 0069-046
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Methotrexate Injection, USP 50 mg/2mL (25 mg/mL) 5 x 2mL Single-Dose Vials, Sterile, Rx Only, Distributed by Hospira, In
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls LYRICA (pregabalin) capsules, 200mg 90-count bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY,
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Triamcinolone Acetonide Ointment, USP, 0.025% 80g; Rx Only, Distributed by: Perrigo, Allegan, MI 49010,NDC 45802-054-36
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls HYDROCORTISONE ACET 30MG 12; RX; SUPPOSITORY,Rx Only, Distributed by: Perrigo, Allegan, MI 49010, NDC: 0574-7093-12
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Podofilox Topical Solution 0.5% 3.5ML, Rx Only, For Topical Use Only, Manufactured by Perrigo, Minneapolis, MN 55427, ND
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Cetirizine Hydrochloride Tablets, 10 mg, 300 Count; NDC/UPC 345802919878; OTC; TABLETS
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls LORATADINE 10MG 100 ND 24H; NDC/UPC 345802650788; OTC; TABLETS
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine Non-Drowsy 100 Tablets 180 mg Each NDC 45802-571-78 Distributed
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls POLYETHYLENE GLYCOL 3350 Powder for Solution Osmotic Laxative 14 once-daily doses 14 Packet- Newt Wt. 0.5 oz (17g) each
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Polyethylene Glycol 3350 Powder for Solution, Laxative Net Wt 4.1 oz (119 g) 7 Once-Daily Doses NDC 45802-868-01 Distrib
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Benzoyl Peroxide 10% Acne Medication Wash Net Wt 5 oz (142 g) Distributed By Perrigo Allegan, MI 49010, NDC 45802-318-01
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Benzoyl Peroxide 2.5% Aqueous Base, Acne Treatment Gel Net Wt. 2.1 oz (60 g) NDC 45802-101-96 Distributed By Perrigo All
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls RISPERIDONE 1MG/ML 30ML; NDC/UPC 50458059601; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS)
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.) NDC 39328-063-25 Manufactured in USA Patrin Pharm
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls ZOLPIDEM TARTRATE SUBLINGUAL TABLET 3.5 MG 30 UNIT DOSE POUCHES; NDC/UPC 49884089911; RX; EACH POUCH CONTAINS ONE SUBL
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Lamotrigine Extended-Release Tablets 250 mg 30 Tablets Rx Only NDC 49884-604-11 Manufactured by: Zhejiang Huahai Pharmac
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.