The Recall Desk

FDA (Drugs) recall action 87512

Cardinal Health Inc. recalled 198 products on 2021-06-02

The FDA (Drugs) publishes a recall like this one as 198 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 198 pages.

Products
198
Announced
2021-06-02
Critical
0
Units
126,679

Why these products were recalled

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

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.

States named across these recalls

1–25 of 198

  • ModerateFDA (Drugs)··2021-06-02

    Cardinal Health Recalls Belsomra Tablets Due to Temperature Excursions

    Cardinal Health is recalling 119 cartons of Belsomra (suvorexant) 10 mg tablets due to intermittent temperature excursions during storage.

    Product
    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…
    Category
    Distribution
    3 states
  • ModerateFDA (Drugs)··2021-06-02

    Cardinal Health Recalls Folivane-Plus Capsules Due to Temperature Excursions

    Cardinal Health is recalling 80 bottles of Folivane-Plus capsules because they were intermittently exposed to temperature excursions during storage.

    Product
    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
    Category
    Distribution
    3 states
  • ModerateFDA (Drugs)··2021-06-02

    Cardinal Health Recalls Restora Omega-3 Supplement Due to Temperature Excursions

    Cardinal Health Inc. is recalling 31 cartons of Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules due to intermittent exposure to temperature excursions during storage.

    Product
    Restora 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
    Category
    Distribution
    3 states
  • ModerateFDA (Drugs)··2021-06-02

    Cardinal Health Recalls Gemcitabine Injection Due to Temperature Excursions

    Cardinal Health is recalling Gemcitabine Injection 200mg/5.26ml vials due to intermittent temperature excursions during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL
    Category
    Distribution
    3 states
  • ModerateFDA (Drugs)··2021-06-02

    Cardinal Health Recalls Advair HFA Inhalers Due to Temperature Excursions

    Cardinal Health is recalling 297 units of Advair HFA inhalers due to intermittent temperature exposure during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    ADVAIR HFA 45-21MCG 12GM; NDC/UPC 173071520; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
    Category
    Distribution
    3 states
  • ModerateFDA (Drugs)··2021-06-02

    Cardinal Health Recalls Proair HFA Inhalers Due to Temperature Excursions

    Cardinal Health Inc. is recalling 26,895 Proair HFA inhalers due to intermittent exposure to temperature excursions during storage.

    Product
    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
    Category
    Distribution
    3 states
  • ModerateFDA (Drugs)··2021-06-02

    Cardinal Health Recalls Vitamin D3 Tablets Due to Temperature Excursions

    Cardinal Health Inc. is recalling 19 bottles of Vitamin D3 25mcg tablets because they were intermittently exposed to temperature excursions during storage.

    Product
    VITAMIN D3 25MCG 180 TABLETS; NDC/UPC 880681168011; OTC; TABLETS
    Category
    Distribution
    3 states
  • ModerateFDA (Drugs)··2021-06-02

    Cardinal Health Recalls Zolpidem Tablets Due to Temperature Excursions

    Cardinal Health is recalling 55 boxes of Zolpidem Tartrate Sublingual Tablets 3.5 mg due to intermittent exposure to temperature excursions during storage.

    Product
    ZOLPIDEM TARTRATE SUBLINGUAL TABLET 3.5 MG 30 UNIT DOSE POUCHES; NDC/UPC 49884089911; RX; EACH POUCH CONTAINS ONE SUBLINGUAL TABLET
    Category
    Distribution
    3 states
  • ModerateFDA (Drugs)··2021-06-02

    Cardinal Health Recalls Benzoyl Peroxide Acne Wash Due to Temperature Excursions

    Cardinal Health is recalling 31 bottles of Benzoyl Peroxide 10% Acne Medication Wash due to intermittent temperature exposure during storage. The product was distributed in Florida, Georgia, and South Carolina.

    Product
    Benzoyl Peroxide 10% Acne Medication Wash Net Wt 5 oz (142 g) Distributed By Perrigo Allegan, MI 49010, NDC 45802-318-01
    Category
    Distribution
    3 states