Accord Healthcare, Inc. recalls Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured…
CGMP Deviations: recalling drug products following an FDA inspection.
Read the official notice →- Date
- 2023-03-08
- Country
- United States
- Brand
- Accord Healthcare
- Product
- Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured…
- Classification
- Class II
- Units
- United States including Puerto Rico and Canada
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Accord Healthcare recalls
- 2024-10-23
US
ACCORD HEALTHCARE, INC. recalls Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare…
Failed Impurities/Degradation Specifications.
- 2024-07-10
US
Accord Healthcare, Inc. recalls Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Healthcare, Inc.,…
Subpotent drug: out of specification results
- 2023-07-19
US
Accord Healthcare, Inc. recalls Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured…
Presence of Particulate Matter: Particulate matter identified as fiber.
- 2023-04-12
US
Accord Healthcare, Inc. recalls Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutaneous Use Only, Rx…
Sub-potent drug: assay test result below specifications at 9-month timepoint.
- 2023-02-01
US
Accord Healthcare, Inc. recalls Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by:…
Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
- 2023-01-25
US
Accord Healthcare, Inc. recalls Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703…
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Other drugs & medical recalls in the United States
- 2023-03-08
US
Baxter Healthcare Corporation recalls Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals
There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
US
Volt Candy Wholesale Club recalls PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier Group,…
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement,…
US
The Harvard Drug Group recalls Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech…
Packaging defect: observed packaging defect, blister packaging inadequately sealed.
US
Nephron Sc Inc recalls Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, SC 29172, NDC…
CGMP Deviations: Potential product carryover.
US
US