Tài nguyên an toàn

Chúng tôi đã thu thập thông tin từ các bản phát hành báo chí và các công bố khác về nhớ lại các sản phẩm có quy định của Cục quản lý dược và thực phẩm (FDA) để chia sẻ với bạn.

Medication Safety Bulletins

If your patient is taking any of the products below:

  • Please have them consider changing to a different medication for their condition.
  • Remind them to return the recalled medication to their pharmacy.

Below are recent nationwide medication recalls and notices:

  • Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL
    Manufacturer: Amneal Pharmaceuticals, LLC
    Recall Date: 11/08/2019
    Reason: Due to potential N-Nitrosodimethylamine (NDMA) amounts being above levels established by the FDA.
    FDA Notice
  • Ranitidine Tablets 150mg, Ranitidine Capsules 150 mg, Ranitidine Capsules 300 mg and Ranitidine Syrup 15 mg/mLRanitidine Tablets, Capsules, and Syrup
    Manufacturer: Aurobindo Pharma USA, Inc.
    Recall Date: 11/06/2019
    Reason: Due to the detection of Nitrosodimethylamine (NDMA) impurity.
    FDA Notice
  • Ranitidine Syrup (Oral Solution, USP), 15 mg/mL
    Manufacturer: Lannett Company, Inc.
    Recall Date: 10/25/2019
    Reason: Due to levels of N-Nitrosodimethylamine (NDMA) being above the levels recently established by the FDA.
    FDA Notice
  • Ranitidine Tablets & Capsules
    Manufacturer: Dr. Reddy’s Laboratories Ltd.
    Recall Date: 10/23/2019
    Reason: Contamination with N-Nitrosodimethylamine (NDMA) above the levels established by the FDA.
    FDA Notice
  • Losartan Potassium 50mg and Losartan Potassium/Hydrochlorothiazide combination Tablets 50mg/12.5mg, 100mg/12.5mg and 100mg/25mg
    Recall Date: 06/26/2019
    Manufacturer: Macleods Pharmaceuticals, Ltd.
    Reason: Detection of trace amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the interim acceptable daily intake levels released by the FDA.
    FDA Notice 
  • Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg
    Recall Date: 02/22/2019
    Manufacturer: Macleods Pharmaceuticals, Ltd.
    Reason: Detection of trace amounts of an unexpected impurity (NDEA) above the interim acceptable daily intake levels released by the FDA.
    FDA Notice 
  • Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP
    Recall Date: 01/22/19
    Manufacturer: Torrent Pharmaceuticals Limited
    Reason: Detection of trace amounts of an N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.
    FDA Notice 
  • Irbesartan and Irbesartan HCTZ Tablets
    Recall Date: 01/18/2019
    Manufacturer: Prinston Pharmaceutical Inc. dba Solco Healthcare LLC
    Reason: Detection of trace amount of N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.
    FDA Notice
  • Valsartan and Valsartan-HCTZ Tablets, USP
    Recall Date: 07/18/2018
    Manufacturers: Prinston Pharmaceuticals, and TEVA Pharmaceuticals.
    Reason: It has been found that the recalled products for impurity detected. This may cause unexpected health risks.
    FDA Notice – Prinston Pharmaceuticals
    FDA Notice – TEVA Pharmaceuticals