June 2, 2021DrugsFDA
Cardinal Health Inc. recalls FLOVENT DISKUS 100MCG 60; NDC/UPC 173060202; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 Genentech
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Prenatal Tablets Gluten Free Multivitamin/ Multimineral Dietary Supplement for Pregnant and Lactating Women UD 100 Table
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP 10-30-2MG/5ML 473ML; NDC
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Narcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box contains two (2) 4-mg doses of naloxone HCl in 0.1 mL of nasal
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Banzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manufactured by Eisai Co., Ltd. Marketed by Eisa
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Ivermectin Tablets USP 3 mg 20 Tablets (2 Foil Strips of 10 tablets each) Rx Only NDC 4799-806-01 Manufactured for: Eden
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Phenobarbital Tablets, USP 32.4 mg 100 tablets Rx only NdC 13517-111-01 Manufactured for: e5 Pharma, LLC., Boca Raton, F
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls PREGABALIN CAPSULES 300MG 90 ; NDC 43598-298-90; RX; CAPSULES
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls BENICAR 40MG 30; NDC/UPC 65597010430; RX; TABLETS
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Iron 100 with Vitamin C Tablets Dietary Supplement 100 Tablets NDC 60258-099-01 Distributed By: Cypress Pharmaceutical,
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Prilosec (Omeprazole Magnesium) For Delayed-Release Oral Suspension 10 mg Rx only NDC 70515-610-01 Mfd. for: Covis Pharm
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls CIPROFLOX/D5W 400/200 24X200ML; NDC/UPC 36000000924; RX; IV SOLUTION (PIGGYBACK)
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Nadolol Tablets, USP 40 mg 100 Tablets Rx Only NDC 69097-868-07 Manufactured for: Cipla USA Inc. 9100 S. Dadeland Blvd.,
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Meloxicam Tablets, USP 7.5 mg 100 Tablets Rx Only NDC 69097-158-07 Manufactured for: Cipla USA, Inc. 9100 S. Dadeland Bl
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser (sodium sulfacetamide 9.8% and sulfur 4.8%) Net Wt. 10 oz. (285 g) Rx O
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC 59746-360-30 Manufactured by: Jubilant Generics Ltd. Roorkee-2
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls PRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETS
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/1000 mg 30 tablets Rx only NDC 05
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Jentadueto XR (linagliptin and metformin hydrochloride extended-release) Tablets 5 mg/1000 mg 30 tablets Rx only NDC 059
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Synjardy (empagliflozin and metformin hydrochloride) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0168-69 Distrib
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Glyxambi (empagliflozin and linagliptin) Tablets 25 mg/5 mg 30 tablets Rx only NDC 0597-0164-30 Dist. by: Boehringer Ing
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls ATROVENT HFA 17MCG 12.9GM; NDC/UPC 597008717; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg (as tiotropium) per capsule Rx
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls CATAPRES-TTS-2 1X4; NDC/UPC 597003234; RX; ADHESIVE PATCHES
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAPID DISSOLUTION (NOT SUBLINGUAL)
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls SYMPROIC (NAIDEMEDINE) TABLETS 0.2MG 30 TABLETS; NDC 59385-041-30; RX; TABLETS
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-025
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-023
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.