The Recall Desk

FDA (Drugs) recall action 89450

CARDINAL HEALTHCARE recalled 42 products on 2024-01-03

The FDA (Drugs) publishes a recall like this one as 42 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 42 pages.

Products
42
Announced
2024-01-03
Critical
0
Units
77

Why these products were recalled

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

26–42 of 42

  • ModerateFDA (Drugs)··2024-01-03

    Leader Nasal Decongestant PE recalled due to improper storage conditions

    Cardinal Healthcare is recalling Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg, 18-tablet cartons) nationwide because products were exposed to temperatures outside the labeled storage conditions. Batch P125514 is affected.

    Product
    Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2024-01-03

    Albuterol Sulfate Inhaler Recalled Due to Temperature Storage Deviation

    Cardinal Healthcare is recalling Albuterol Sulfate inhalers (Batch K100715) due to CGMP deviations where products were exposed to temperatures outside labeled storage conditions. Approximately 11 cartons were distributed nationwide. Contact your pharmacist or doctor for a replacement.

    Product
    ALBUTEROL SULFATE (ALBUTEROL SULFATE)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2024-01-03

    FDA recalls Asmanex asthma inhalation powder for improper storage conditions

    Cardinal Healthcare is recalling Asmanex Twisthaler inhalers (batch U027458) because they were exposed to temperatures outside their labeled storage conditions. The FDA classified this as a Class II recall due to the manufacturing deviation.

    Product
    ASMANEX (MOMETASONE FUROATE)
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2024-01-03

    Warfarin Sodium Tablets Recalled Due to Temperature Storage Deviation

    Cardinal Healthcare recalls Warfarin Sodium Tablets (5 mg) nationwide due to CGMP deviations: products were exposed to temperatures outside labeled storage conditions, potentially affecting drug stability.

    Product
    WARFARIN SODIUM (WARFARIN SODIUM)
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2024-01-03

    Rivastigmine Transdermal Patch Recalled Due to Temperature Exposure

    Cardinal Healthcare is recalling Rivastigmine Transdermal System patches (4.6 mg/24 hours) distributed nationwide because they were exposed to temperatures outside labeled storage conditions during manufacturing.

    Product
    RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc., Morristown, NJ 07960. NDC 47781-304-03
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2024-01-03

    Amoxicillin tablets recalled due to improper storage temperature exposure

    Cardinal Healthcare is recalling Amoxicillin 875mg tablets due to CGMP deviations where products were exposed to temperatures outside their labeled storage conditions, affecting nationwide distribution.

    Product
    AMOXICILLIN (AMOXICILLIN)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2024-01-03

    Colgate Total SF Toothpaste recalled for improper storage temperature exposure

    Colgate Total SF Toothpaste (Batch 1293US561C, 4.8 oz, Clean Mint) distributed nationwide is being recalled due to CGMP deviations where products were exposed to temperatures outside labeled storage conditions.

    Product
    Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%, Clean Mint, Dist. by: COLGATE-PALMOLIVE CO., New York, NY 10022 USA
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2024-01-03

    Lansoprazole Suspension Recalled Due to Temperature Storage Deviations

    A prescription lansoprazole suspension has been recalled because batches were exposed to temperatures outside the manufacturer's labeled storage range. This manufacturing quality issue affects Batch 21025A nationwide.

    Product
    FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn, MA 01801. NDC: 65628-080-10
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2024-01-03

    PredniSONE Tablets Recalled for Temperature Storage Deviation

    Cardinal Healthcare is recalling PredniSONE 20 mg tablets nationwide (Batch 21P0659, NDC 59746-175-06) due to exposure to temperatures outside labeled storage conditions during manufacture, which could affect drug stability.

    Product
    PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801. NDC: 59746-175-06
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2024-01-03

    Triamterene and Hydrochlorothiazide Capsules Recalled for Temperature Storage Deviation

    Triamterene and Hydrochlorothiazide Capsules (37.5 mg/25 mg) are being recalled nationwide due to temperature exposure during manufacturing that fell outside labeled storage conditions. Affected batches are 21000279A and 21000280A.

    Product
    Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19136. NDC 0527-1632-01
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2024-01-03

    Drug Recall: Hydralazine Hydrochloride Tablets Due to Improper Storage

    Cardinal Healthcare is recalling Hydralazine Hydrochloride tablets nationwide because products were exposed to temperatures outside labeled storage conditions due to manufacturing practice deviations.

    Product
    HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE HYDROCHLORIDE)
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2024-01-03

    Low-dose aspirin recall due to improper storage temperature conditions

    Cardinal Healthcare is recalling low-dose aspirin tablets nationwide due to a CGMP deviation involving improper storage temperatures. Products may have been exposed to conditions outside the manufacturer's labeled storage requirements, potentially affecting product stability.

    Product
    ASPIRIN (ASPIRIN)
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2024-01-03

    Bumetanide Tablets Recalled for Exposure to Improper Storage Temperatures

    Bumetanide tablets manufactured by Amneal Pharmaceuticals are being recalled because they were exposed to temperatures outside their labeled storage conditions. The recall affects batch AM211171 distributed nationwide.

    Product
    Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213 India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2024-01-03

    Lithium Carbonate Extended-Release Tablets Recalled for Temperature Excursion

    Cardinal Healthcare recalled Lithium Carbonate Extended-Release Tablets (300 mg, Batch 3138326) distributed nationwide because the products were exposed to temperatures outside their labeled storage conditions during manufacturing.

    Product
    Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-1300-01
    Category
    Distribution
    0 states