Drug and pharmaceutical recalls
17707 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIRestora 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
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IITRAMADOL HYDROCHLORIDE TABLETS USP 100MG, 100-count bottle, Rx Only, Manufactured by: Rubicon Research :Private Limited, Ambernath, Dist. Thane, 421506 India, NDC: 52817-0196-10
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIFolivane-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.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIDarifenacin Extended-release Tablets 15 mg 30 Tablets Rx only, Manufactured by: Torrent Pharmaceuticals, LTD Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13668-203-30
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIDarifenacin Extended-release Tablets 7.5 mg 30 Tablets Rx only Manufactured by: Torrent Pharmaceuticals LTD. Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13668-202-30
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IISulindac Tablets, USP, 200mg 100-count bottles, Rx Only, Manufactured by: Epic Pharma, LLC, Laurelton, NY 11413, NDC 42806-011-01
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIDesvenlafaxine Extended-Release Tablets 25 mg 30 Tablets Rx Only NDC 0591-4060-30 Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IILevalbuterol 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
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIBalziva 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
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIEPINEPHRINE 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
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIEPINEPHRINE INJECTION USP, 0.3MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-5986-27
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIPENICILLIN V POT for Oral Solution, USP 125mg/5mL 100mL (when mixed) Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4125-73
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIBISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg, 100-count bottles, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-3241-01 RX; TABLETS
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IINEOMYCIN SULF TABLETS, USP, 500mg, 100-count bottle, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC: 0093-1177-01
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIProair 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.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIChildren'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
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIColcrys (colchicine, USP) tablets 0.6 mg 30 tablets Rx only Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015,NDC 64764-119-07
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IITrokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufactured by: Catalent Pharma Solutions Winchester, KY 40391 USA Manufactured for: Supernus Pharmaceuticals, Inc. Rockville, MD 20850 USA, NDC 17772-103-30
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IICOREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bottle, Rx Only,/UPC 57664066683
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IICLINDAMYCIN HYDROCHLORIDE CAPSULES, USP,150MG 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-692-01
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IICollagenase Santyl Ointment 250 units/g 30 grams Rx Only Marketed by Smith & Nephew, Inc., Fort Worth, TX 76107, NDC 50484-010-30
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IITuberculin Purified Protein Derivative (Mantous) TUBERSOL, Stabilized Solution 5 US Units, Rx Only Sanofi Pasteur Limited, NDC 49281-752-21
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIHYDROCORTISONE 1% 30gm cream
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IICefazolin for Injection, USP 1 gram per vial Rx Only Single-use Vial Sterile Manufactured in Austria by Sandoz GmbH for Sandoz, Inc., Princeton, NJ 08540, NDC 0781-3451-70
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IImedroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-4538-02
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIMedroxyprogesterone 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.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIBudesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonide 80 mcg/formoterol fumarate dihydrate 4.5 mcg Inhalation Aerosol 120 inhalations Rx only Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, NDC 0310-7372-20
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIIntrarosa 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
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IINature'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.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIPROMETHAZINE 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.
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