Drug and pharmaceutical recalls
17624 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 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.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IILEVOXYL Tablets, USD, 150MCG, 100-count bottle, Rx Only, Distributed by Pfizer Inc., New York, NY 10017, MADE IN AUSTRIA, NDC: 60793-858-01
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIChantix (varenicline) Tablets Starting Pack Contains: 1 Starting Week (0.5 mgx11 tablets) 3 Continuing Weeks (1 mgx42 tablets) Rx only NDC 0069-0471-03 Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY 10017
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIChantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only ; Rx only Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY ,10017NDC 0069-0469-56
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIChantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only NDC 0069-0469-03 Distributed by Pfizer Labs Division of Pfizer Inc., NY, NY 10017
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIMethotrexate 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.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IILYRICA (pregabalin) capsules, 200mg 90-count bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, MADE IN SINGAPORE
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IITriamcinolone Acetonide Ointment, USP, 0.025% 80g; Rx Only, Distributed by: Perrigo, Allegan, MI 49010,NDC 45802-054-36
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIHYDROCORTISONE ACET 30MG 12; RX; SUPPOSITORY,Rx Only, Distributed by: Perrigo, Allegan, MI 49010, NDC: 0574-7093-12
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIPodofilox Topical Solution 0.5% 3.5ML, Rx Only, For Topical Use Only, Manufactured by Perrigo, Minneapolis, MN 55427, NDC 0574-0611-05.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IICetirizine Hydrochloride Tablets, 10 mg, 300 Count; NDC/UPC 345802919878; OTC; TABLETS
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IILORATADINE 10MG 100 ND 24H; NDC/UPC 345802650788; OTC; TABLETS
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIFexofenadine 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.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIPOLYETHYLENE GLYCOL 3350 Powder for Solution Osmotic Laxative 14 once-daily doses 14 Packet- Newt Wt. 0.5 oz (17g) each NDC 45802-868-66
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIPolyethylene 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
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIBenzoyl Peroxide 10% Acne Medication Wash Net Wt 5 oz (142 g) Distributed By Perrigo Allegan, MI 49010, NDC 45802-318-01
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIBenzoyl 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
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIRISPERIDONE 1MG/ML 30ML; NDC/UPC 50458059601; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIHySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.) NDC 39328-063-25 Manufactured in USA Patrin Pharma, Skokie, IL 60076
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIZOLPIDEM TARTRATE SUBLINGUAL TABLET 3.5 MG 30 UNIT DOSE POUCHES; NDC/UPC 49884089911; RX; EACH POUCH CONTAINS ONE SUBLINGUAL TABLET
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IILamotrigine Extended-Release Tablets 250 mg 30 Tablets Rx Only NDC 49884-604-11 Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Zhejiang 317024 China For Par Pharmaceutical Companes, Inc. Spring Valley, NY 10977 U.S.A.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIBenztropine 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.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIRybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30 tablets 3 blister packs. Each pack contains 10 tablets. Rx only NDC 0169-4307-13 Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd, Denmark
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IICIPRODEX (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.
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