Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0442-2021 | 03-15-2021 | Nuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60 capsules Rx only NDC 64597-301-60 Manufactured by Patheon, Inc. Whitby, ON L1N 5Z5, Canada Package NDCs: 64597-301-13; 64597-301-60 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 255 bottles | Class II | Terminated |
| D-0421-2021 | 03-15-2021 | 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. Package NDCs: 47781-306-01; 47781-307-01; 47781-308-01 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 15 bottles | Class II | Terminated |
| D-0453-2021 | 03-15-2021 | Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg (as tiotropium) per capsule Rx only NDC 0597-0075-41 Manufactured by: Boehringer Ingelheim (BI) Pharma GmbH & Co. KG Ingelheim, Germany Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA and Pfizer, Inc. New York, NY 10017 USA Package NDCs: 0597-0075-41; 0597-0075-75; 0597-0075-47 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 2611 inhalers | Class II | Terminated |
| D-0463-2021 | 03-15-2021 | Meloxicam Tablets, USP 7.5 mg 100 Tablets Rx Only NDC 69097-158-07 Manufactured for: Cipla USA, Inc. 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156 Package NDCs: 69097-158-15; 69097-158-07; 69097-158-12; 69097-159-12; 69097-159-07; 69097-159-15 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 576 bottles | Class II | Terminated |
| D-0535-2021 | 03-15-2021 | CIPRODEX (CIPROFLOXACIN 0.3 AND DEXAMETHASONE 0.1%) 7.5ML; NDC/UPC 0078-0799-75; RX; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 341 CARTON | Class II | Terminated |
| D-0513-2021 | 03-15-2021 | Acne Medication Benzoyl Peroxide Gel USP, 5% Net Wt 1.5 oz (42.5 g) NDC 0536-1055-56 Distributed by: Rugby Laboratories 31778 Enterprise Drive, Livonia, MI 48150 Package NDCs: 0536-1055-56; 0536-1055-25; 0536-1055-57 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 189 tubes | Class II | Terminated |
| D-0404-2021 | 03-15-2021 | Norvir Ritonavir Tablets 100 mg 30 Tablets Rx only NDC 0074-3333-30 Abbott Laboratories North Chicago, IL 60064, U.S.A. Package NDCs: 0074-3333-30; 0074-1940-63; 0074-3399-30; 0074-2340-30 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 362 bottles | Class II | Terminated |
| D-0473-2021 | 03-15-2021 | 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 spray. 0.1 mL intranasal spray per unit For use in the nose only Rx only NDC 69547-353-02 Distributed by Adapt Pharma, Inc. Radnor, PA 19087 USA Package NDCs: 69547-353-02 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 11189 plungers | Class II | Terminated |
| D-0427-2021 | 03-15-2021 | Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles Rx Only NDC 60505-0813-1 Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Package NDCs: 60505-0813-1 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 38 bottles | Class II | Terminated |
| D-0508-2021 | 03-15-2021 | TRI-LO-MARZIA 0.180MG/0.025MG; 0.215 MG/0.025MG AND 0.250MG/0.025MG 3X28 BPK; NDC/UPC 68180-837-73; RX; TABLETS Package NDCs: 68180-837-73 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 60 CARTON | Class II | Terminated |
| D-0572-2021 | 03-15-2021 | Children's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) Allergy Grape Flavor 4 FL OZ (120 mL) NDC 51672-2131-8 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 Package NDCs: 51672-2131-4; 51672-2131-8; 51672-2131-1 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 2907 bottles | Class II | Terminated |
| D-0520-2021 | 03-15-2021 | CARBIDOPA AND LEVORDOPA TABLETS, USP 25MG/100MG 100 TABLETS; NDC/UPC 51862-856-01; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 407 BOXES | Class II | Terminated |
| D-0407-2021 | 03-15-2021 | FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04; RX; CAPSULES Package NDCs: 27241-118-04; 27241-118-05; 27241-119-04; 27241-119-05; 27241-120-04; 27241-120-05 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 106 BOXES | Class II | Terminated |
| D-0579-2021 | 03-15-2021 | Balziva 28 Day (norethindrone and ethinyl estradiol tablets USP) 6 Blister Card Dispensers, 28 tablets each, Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-9034-58 Package NDCs: 0555-9034-79; 0555-9034-58 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 23 bottles | Class II | Terminated |
| D-0523-2021 | 03-15-2021 | Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant. This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets. Rx only NDC 0006-0335-30 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08880, USA Package NDCs: 0006-0005-10; 0006-0005-30; 0006-0005-13; 0006-0033-10; 0006-0033-30; 0006-0033-13; 0006-0325-10; 0006-0325-30; 0006-0325-13; 0006-0335-10; 0006-0335-30; 0006-0335-13 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 299 cartons | Class II | Terminated |
| D-0510-2021 | 03-15-2021 | TRAZODONE HYDROCHLORIDE TABLETS, USP 50MG 100 TABLET 10X10UD; NDC/UPC 0904-6868-61; RX; TABLETS Package NDCs: 0904-6868-61; 0904-6869-61; 0904-7212-61 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 91 CARTON | Class II | Terminated |
| D-0527-2021 | 03-15-2021 | Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly) Delivers 0.1 mg/day Rx only NDC 0378-4623-26 Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-4619-16; 0378-4619-26; 0378-4620-16; 0378-4620-26; 0378-4621-16; 0378-4621-26; 0378-4622-16; 0378-4622-26; 0378-4623-16; 0378-4623-26 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 72 cartons | Class II | Terminated |
| D-0528-2021 | 03-15-2021 | Epinephrine Injection, USP Auto-Injectors in all strengths, packs and styles Manufactured for Mylan Specialty L.P., Morgantown, WV , NDC: 9502-500-01, 49502-500-02, 49502-500-92, 49502-501-01 Package NDCs: 49502-500-01; 49502-500-02; 49502-500-92; 49502-501-01; 49502-501-02; 49502-501-92 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 620 injector | Class II | Terminated |
| D-0450-2021 | 03-15-2021 | SYMPROIC (NAIDEMEDINE) TABLETS 0.2MG 30 TABLETS; NDC 59385-041-30; RX; TABLETS Package NDCs: 59385-041-30; 59385-041-07 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 67 BOXES | Class II | Terminated |
| D-0423-2021 | 03-15-2021 | Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL contains 6 mg oseltamivir base after constitution. 60 mL (usable volume after constitution) Rx Only NDC 47781-384-26 Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA Package NDCs: 47781-384-26 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 15885 bottles | Class II | Terminated |
| D-0553-2021 | 03-15-2021 | Methotrexate Injection, USP 50 mg/2mL (25 mg/mL) 5 x 2mL Single-Dose Vials, Sterile, Rx Only, Distributed by Hospira, Inc. Lake Forest, IL 60045. NDC 61703-350-38. Package NDCs: 61703-350-37; 61703-350-38; 61703-408-41 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 341 vials | Class II | Terminated |
| D-0480-2021 | 03-15-2021 | Arnuity Ellipta (fluticasone furoate inhalation powder) 200 mcg 1 Ellipta Inhaler containing 1 Foil Strip of 30 Blisters Rx Only NDC 0173-0876-10 GlaxoSmithKline Research Triangle Park, NC 27709 Package NDCs: 0173-0888-10; 0173-0874-10; 0173-0874-14; 0173-0876-10; 0173-0876-14 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 353 inhalers | Class II | Terminated |
| D-0428-2021 | 03-15-2021 | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 31 droptainers | Class II | Terminated |
| D-0461-2021 | 03-15-2021 | Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC 59746-360-30 Manufactured by: Jubilant Generics Ltd. Roorkee-247661, India Package NDCs: 59746-360-30; 59746-360-90; 59746-360-05; 59746-360-03; 59746-361-30; 59746-361-90; 59746-361-05; 59746-361-03; 59746-362-30; 59746-362-90; 59746-362-05; 59746-362-03; 59746-363-30; 59746-363-90; 59746-363-67; 59746-363-32 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 20 bottles | Class II | Terminated |
| D-0491-2021 | 03-15-2021 | Calcium Acetate Capsules 667 mg 200 Capsules Rx only NDC 23155-531-02 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 Package NDCs: 23155-531-02; 23155-531-10; 23155-531-18 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 35 bottles | Class II | Terminated |
| D-0430-2021 | 03-15-2021 | edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/12.5 mg 30 Tablets Rx Only NDC 60631-412-30 Manufactured for: arbor Pharmaceuticals, LLC. Atlanta, GA 30328 Package NDCs: 60631-412-30; 60631-425-30 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 244 bottles | Class II | Terminated |
| D-0582-2021 | 03-15-2021 | Sulindac Tablets, USP, 200mg 100-count bottles, Rx Only, Manufactured by: Epic Pharma, LLC, Laurelton, NY 11413, NDC 42806-011-01 Package NDCs: 42806-018-01; 42806-018-05; 42806-018-10; 42806-011-01; 42806-011-05; 42806-011-10 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 92 bottles | Class II | Terminated |
| D-0431-2021 | 03-15-2021 | edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/25 mg *Each tablet contains: 42.68 mg azilsartan kamedoxomil (equivalent to 40 mg azilsartan medoxomil) and 25 mg chlorthalidone. 30 Tablets Rx Only NDC 60631-425-30 Manufactured for Arbor Pharmaceuticals Atlanta, GA 30328 Package NDCs: 60631-412-30; 60631-425-30 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 273 bottles | Class II | Terminated |
| D-0429-2021 | 03-15-2021 | Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328 Package NDCs: 60631-040-07; 60631-040-30; 60631-040-77; 60631-080-07; 60631-080-30; 60631-080-77 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 328 bottles | Class II | Terminated |
| D-0542-2021 | 03-15-2021 | Benzoyl Peroxide 2.5% Aqueous Base, Acne Treatment Gel Net Wt. 2.1 oz (60 g) NDC 45802-101-96 Distributed By Perrigo Allegan, MI 49010 Package NDCs: 45802-101-96 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 5 tubes | Class II | Terminated |
| D-0562-2021 | 03-15-2021 | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 286 syringes | Class II | Terminated |
| D-0517-2021 | 03-15-2021 | DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL OINTMENT 28GM ; NDC/UPC 0536-1211-95; OTC; OINTMENT Package NDCs: 0536-1211-95 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 701 CARTON | Class II | Terminated |
| D-0497-2021 | 03-15-2021 | Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain Reliever Fever Reducer 20 Liquid Gels 325 mg each NDC 50580-487-20 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 37 bottles | Class II | Terminated |
| D-0593-2021 | 03-15-2021 | HALOPERIDOL TABLETS 20mg, USP, 100-count bottle, Rx Only Distributed by: Usher-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC: 0832-1560-11 Package NDCs: 0832-1510-11; 0832-1520-11; 0832-1520-89; 0832-1520-01; 0832-1530-11; 0832-1540-11; 0832-1540-89; 0832-1540-01; 0832-1550-11; 0832-1550-89; 0832-1550-01; 0832-1560-11 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 35 BOTTLE | Class II | Terminated |
| D-0413-2021 | 03-15-2021 | BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS Package NDCs: 62332-508-17 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 152 CARTON | Class II | Terminated |
| D-0472-2021 | 03-15-2021 | Banzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manufactured by Eisai Co., Ltd. Marketed by Eisai Inc. Woodcliff Lake, NJ 07677 Package NDCs: 62856-582-52; 62856-582-04; 62856-583-14; 62856-583-52; 62856-584-46 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 30 bottles | Class II | Terminated |
| D-0426-2021 | 03-15-2021 | ENOXAPARIN DOFIUM INJRVYION, UPD 150MG/1ML 10X1ML SINGLE DOSE SYRINGES; NDC/UPC 60505-0798-4; RX; SYRINGES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 64 BOXES | Class II | Terminated |
| D-0526-2021 | 03-15-2021 | Levothyroxine Sodium Tablets, USP 125 mcg (0.125 mg) 90 Tablets Rx only NDC 0378-1813-77 Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 112 bottles | Class II | Terminated |
| D-0514-2021 | 03-15-2021 | VITAMIN D3 50MCG 100 SOFTGELS; NDC/UPC 880681009000; OTC; GELCAP | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 380 BOTTLE | Class II | Terminated |
| D-0559-2021 | 03-15-2021 | Nature's Truth Absorbable Calcium 1200 mg plus D3 5000 IU 120 Softgels Dietary Supplements Carefully Designed and Distributed by Nature's Truth LLC. Ronkonkoma, NY 11779, UPC 840093100672 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 8 bottles | Class II | Terminated |
| D-0573-2021 | 03-15-2021 | Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With Dose Counter 200 Metered Inhalation 8,5 g Net Contents Rx only NDC 59310-579-22 Mktd by: Teva Respiratory, LLC Horsham, PA 19044 Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 26895 inhalers | Class II | Terminated |
| D-0320-2021 | 03-15-2021 | Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, NJ 07054 USA, Manufactured by: Sun Pharmaceutical Industries Ltd, Halol, Gujarat, India Made in India, NDC 55566-1000-1. | Failed Impurities/Degradation Specifications | SUN PHARMACEUTICAL INDUSTRIES INC / 91,211 syringes | Class II | Terminated |
| D-0409-2021 | 03-15-2021 | LIDOCAINE HCL VISC 2% 100ML; NDC/UPC 50383077504; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS) | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 240 bottles | Class II | Terminated |
| D-0545-2021 | 03-15-2021 | POLYETHYLENE GLYCOL 3350 Powder for Solution Osmotic Laxative 14 once-daily doses 14 Packet- Newt Wt. 0.5 oz (17g) each NDC 45802-868-66 Package NDCs: 45802-868-01; 45802-868-03; 45802-868-02; 45802-868-66 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 934 boxes | Class II | Terminated |
| D-0546-2021 | 03-15-2021 | Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine Non-Drowsy 100 Tablets 180 mg Each NDC 45802-571-78 Distributed By Perrigo Allegan, MI 49010 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 321 bottles | Class II | Terminated |
| D-0596-2021 | 03-15-2021 | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 15 bottles | Class II | Terminated |
| D-0478-2021 | 03-15-2021 | ADVAIR HFA 45-21MCG 12GM; NDC/UPC 173071520; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 297 inhalers | Class II | Terminated |
| D-0519-2021 | 03-15-2021 | VITAMIN D3 50MCG 100 CALC; NDC/UPC 880681170007; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 427 BOTTLE | Class II | Terminated |
| D-0544-2021 | 03-15-2021 | Polyethylene Glycol 3350 Powder for Solution, Laxative Net Wt 4.1 oz (119 g) 7 Once-Daily Doses NDC 45802-868-01 Distributed by Perrigo Allegan, MI 49010 Package NDCs: 45802-868-01; 45802-868-03; 45802-868-02; 45802-868-66 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 163 bottles | Class II | Terminated |
| D-0465-2021 | 03-15-2021 | CIPROFLOX/D5W 400/200 24X200ML; NDC/UPC 36000000924; RX; IV SOLUTION (PIGGYBACK) | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 40 bags | Class II | Terminated |
| D-0477-2021 | 03-15-2021 | FLOVENT DISKUS 100MCG 60; NDC/UPC 173060202; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 237 inhalers | Class II | Terminated |
| D-0468-2021 | 03-15-2021 | BENICAR 40MG 30; NDC/UPC 65597010430; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 75 bottles | Class II | Terminated |
| D-0460-2021 | 03-15-2021 | PRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 3 bottles | Class II | Terminated |
| D-0516-2021 | 03-15-2021 | VITAMIN D3 25MCG 180 TABLETS; NDC/UPC 880681168011; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 19 BOTTLE | Class II | Terminated |
| D-0415-2021 | 03-15-2021 | UBRELVY 100MG 10UD CPLT; NDC/UPC 23650110; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 964 bottles | Class II | Terminated |
| D-0549-2021 | 03-15-2021 | Podofilox Topical Solution 0.5% 3.5ML, Rx Only, For Topical Use Only, Manufactured by Perrigo, Minneapolis, MN 55427, NDC 0574-0611-05. Package NDCs: 0574-0611-05 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 180 bottles | Class II | Terminated |
| D-0410-2021 | 03-15-2021 | 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. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 424 bottles | Class II | Terminated |
| D-0479-2021 | 03-15-2021 | ARNUITY ELLIPTA 100MCG 30INH; NDC/UPC 173087410; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 513 inhalers | Class II | Terminated |
| D-0597-2021 | 03-15-2021 | Enalapril Maleate Tablets, USP 2.5 mg 100 tablets Rx only Distributed by: Cardinal Health, NDC 64679-923-02 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 10 bottles | Class II | Terminated |
| D-0405-2021 | 03-15-2021 | Synthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles and concentrations Rx only Abbott Laboratories North Chicago, IL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 123 bottles | Class II | Terminated |
| D-0462-2021 | 03-15-2021 | Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser (sodium sulfacetamide 9.8% and sulfur 4.8%) Net Wt. 10 oz. (285 g) Rx Only NDC 50096-502-10 Manufactured for: Rosemar Labs, LLC 2100 West Loop South Suite 900 Houston, TX 77027 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 16 tubes | Class II | Terminated |
| D-0585-2021 | 03-15-2021 | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 80 bottles | Class II | Terminated |
| D-0505-2021 | 03-15-2021 | SILADRYL 12.5/5ML 118ML SF AF; NDC/UPC 354838135404; OTC; LIQUID | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 78 bottles | Class II | Terminated |
| D-0444-2021 | 03-15-2021 | BENZEFOAM EMOLLIENT FOAM BENZOYL PEROXIDE 5.3% 100GM TOP EMOL NDC 187-0194--10; OTC; FOAMS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 2 carton | Class II | Terminated |
| D-0578-2021 | 03-15-2021 | EPINEPHRINE INJECTION USP, 0.15 MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-5985-27 Package NDCs: 0093-5986-19; 0093-5986-27; 0093-5985-19; 0093-5985-27 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1776 boxes | Class II | Terminated |
| D-0471-2021 | 03-15-2021 | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 504 cartons | Class II | Terminated |
| D-0454-2021 | 03-15-2021 | ATROVENT HFA 17MCG 12.9GM; NDC/UPC 597008717; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 667 inhalers | Class II | Terminated |
| D-0492-2021 | 03-15-2021 | LITHIUM CARB 150MG 100; NDC/UPC 54252625; RX; CAPSULES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 298 bottles | Class II | Terminated |
| D-0588-2021 | 03-15-2021 | INTEGRA 325/40/3mg 90-count bottle, NDC: 52747-710-60 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 32 bottles | Class II | Terminated |
| D-0515-2021 | 03-15-2021 | VITAMIN D3 25MCG 90 TABLETS; NDC/UPC 880681168004; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 53 BOTTLE | Class II | Terminated |
| D-0456-2021 | 03-15-2021 | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 284 bottles | Class II | Terminated |
| D-0440-2021 | 03-15-2021 | ONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1935 bottles | Class II | Terminated |
| D-0406-2021 | 03-15-2021 | METHOCARBAMOL 500MG 500; NDC/UPC 71093014005; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 51 bottles | Class II | Terminated |
| D-0594-2021 | 03-15-2021 | Corgard (nadolol tablets, USP) 40 mg 100 Tablets Rx only NDC 27505-101-01 Distributed by US WorldMeds, LLC, Louisville, KY 40241 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 2 bottles | Class II | Terminated |
| D-0589-2021 | 03-15-2021 | VIMPAT(lacosamide) Tablets ,100 mg, 60-count bottle; Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 796 bottles | Class II | Terminated |
| D-0530-2021 | 03-15-2021 | NAT B VIT D3 2000U 100; NDC/UPC 079854041125; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 47 bottles | Class II | Terminated |
| D-0531-2021 | 03-15-2021 | Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 100 Capsules NDC 75834-020-01 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 523 bottles | Class II | Terminated |
| D-0558-2021 | 03-15-2021 | PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS), Rx Only, NDC 0211-0927-16 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 49 CARTON | Class II | Terminated |
| D-0557-2021 | 03-15-2021 | LEVOXYL Tablets, USD, 150MCG, 100-count bottle, Rx Only, Distributed by Pfizer Inc., New York, NY 10017, MADE IN AUSTRIA, NDC: 60793-858-01 Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 13 bottles | Class II | Terminated |
| D-0541-2021 | 03-15-2021 | RISPERIDONE 1MG/ML 30ML; NDC/UPC 50458059601; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS) | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 39 bottles | Class II | Terminated |
| D-0521-2021 | 03-15-2021 | PEDIA-LAX 66ML; NDC/UPC 301320202205; OTC; ENEMA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 147 | Class II | Terminated |
| D-0522-2021 | 03-15-2021 | 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 08889, USA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 119 cartons | Class II | Terminated |
| D-0400-2021 | 03-15-2021 | THERAPEUTIC M 130; NDC/UPC 740985223680; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 55 bottles | Class II | Terminated |
| D-0464-2021 | 03-15-2021 | Nadolol Tablets, USP 40 mg 100 Tablets Rx Only NDC 69097-868-07 Manufactured for: Cipla USA Inc. 9100 S. Dadeland Blvd., Suite 1599 Miami, FL 33156 Package NDCs: 69097-867-07; 69097-867-15; 69097-867-02; 69097-868-02; 69097-868-07; 69097-868-15; 69097-869-02; 69097-869-07; 69097-869-15 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 40 bottles | Class II | Terminated |
| D-0580-2021 | 03-15-2021 | Levalbuterol tartrate HFA Inhalation Aerosol 45 mcg/actuation 200 Metered Inhalations Net Contents: 15 g Rx Only NDC 0591-2927-54 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Package NDCs: 0591-2927-54 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 828 inhalers | Class II | Terminated |
| D-0487-2021 | 03-15-2021 | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 23 tubes | Class II | Terminated |
| D-0503-2021 | 03-15-2021 | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 422 bottles | Class II | Terminated |
| D-0493-2021 | 03-15-2021 | LEUCOVORIN 15MG 24; NDC/UPC 54449810; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 12 bottles | Class II | Terminated |
| D-0443-2021 | 03-15-2021 | LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM; NDC/UPC 24208-0507-07; RX; GEL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 463 boxes | Class II | Terminated |
| D-0504-2021 | 03-15-2021 | Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1.0 mL Alcohol 0.2% v/v Drops Iron Supplement Drops For Infants and Toddlers 50 mL (1 2/3 fl oz) NDC 54838-011-50 Manufactured by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 10977 USA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 357 bottles | Class II | Terminated |
| D-0501-2021 | 03-15-2021 | PHENTERMINE HCL 30MG 100 C4; NDC/UPC 10702002801; RX; CAPSULES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 16 bottles | Class II | Terminated |
| D-0534-2021 | 03-15-2021 | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 348 droptainers | Class II | Terminated |
| D-0569-2021 | 03-15-2021 | COREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bottle, Rx Only,/UPC 57664066683 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 133 bottles | Class II | Terminated |
| D-0511-2021 | 03-15-2021 | MICONAZOLE 7 2% 45GM APL; NDC/UPC 009047734459; OTC; CREAM | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 71 tubes | Class II | Terminated |
| D-0537-2021 | 03-15-2021 | Benztropine Mesylate Tablets, USP in all pack sizes, styles and strengths Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 60 bottles | Class II | Terminated |
| D-0498-2021 | 03-15-2021 | INVEGA SUSTENNA 156MG/1ML; NDC/UPC 50458056301; RX; SYRINGES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 534 syringes | Class II | Terminated |
| D-0446-2021 | 03-15-2021 | TOBRAMY/DEX 0.3-0.1% 10ML OPTH; NDC/UPC 24208029510; RX; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 47 droptainers | Class II | Terminated |
| D-0416-2021 | 03-15-2021 | RESTASIS 0.05%30X 0.4ML OPTH PF; NDC/UPC 23916330; RX; DROPS/Restasis 0.05% 60x0.4 mL OPTH PF; NDC/UPC 23916330; RX | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 3688 bottles | Class II | Terminated |
| D-0574-2021 | 03-15-2021 | NEOMYCIN SULF TABLETS, USP, 500mg, 100-count bottle, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC: 0093-1177-01 Package NDCs: 0093-1177-01 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 41 bottles | Class II | Terminated |
| D-0438-2021 | 03-15-2021 | Eletriptan Hydrobromide Tablets 20 mg* 6(1x6) Unit-dose Tablets Rx only NDC 59651-104-69 Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520 Package NDCs: 59651-104-06; 59651-104-69; 59651-105-06; 59651-105-69; 59651-105-93 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 20 CARTONS | Class II | Terminated |
