Drugs & medicalClass III

AVKARE LLC recalls Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13

Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

Read the official notice →
Date
2023-06-21
Country
United States
Brand
AvKARE
Product
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13
Classification
Class III
Units
Nationwide in the USA.
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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 AvKARE recalls

  1. 2024-12-11
  2. US
  3. 2024-04-24
  4. US
    Drugs & medicalClass I

    AvKARE recalls Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478,…

    Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.

    FDA · DrugAvKAREUS Nationwide.Official notice →
  5. 2023-09-13
  6. US
    Drugs & medicalClass II

    AVKARE LLC recalls Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) NDC 50268-195-60, Manufactured for:…

    Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste

    FDA · DrugAVKARE LLCAffected product was distributed to nineteen (19) consignees within the united…Official notice →
  7. US
    Drugs & medicalClass II

    AVKARE LLC recalls Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET WT. 1.8…

    Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste

    FDA · DrugAVKARE LLCAffected product was distributed to nineteen (19) consignees within the united…Official notice →
  8. 2023-01-04
  9. US
    Drugs & medicalClass II

    AVKARE LLC recalls Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15

    Failed impurities/degradation specifications: Out of specification for unknown impurities.

    FDA · DrugAVKARE LLCUSA NationwideOfficial notice →
  10. 2022-08-17
  11. US
    Drugs & medicalClass III

    AVKARE Inc. recalls Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3…

    Labeling: Label Error on Declared Strength

    FDA · DrugAVKARE Inc.Nationwide within the United StatesOfficial notice →
All 19 AvKARE recalls →

Other drugs & medical recalls in the United States

  1. 2023-06-21
  2. US
    Drugs & medicalClass II

    p-Chip Corporation recalls p-Chip Wand Reader

    The laser operation might fall under a higher laser class.

    FDA · Devicep-Chip CorporationUS Nationwide DistributionOfficial notice →
  3. US
    Drugs & medicalClass I

    NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device

    Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is a risk of nitric oxide leak, oxygen gas leak, or earlier cylinder gas changeover than expected or…

    FDA · DeviceNOXBOX LTDWorldwide distribution - US Nationwide and the countries of Bahrain, Bolivia,…Official notice →
  4. US
    Drugs & medicalClass II

    Amneal Pharmaceuticals of New York, LLC recalls Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal…

    Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)

    FDA · DrugAmneal Pharmaceuticals of New York, LLCLA, PA and OH.Official notice →
  5. US
    Drugs & medicalClass I

    Jarman's Midwest Cleaning Systems, Inc. recalls SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND SANITIZER, NON-STERILE SOLUTION, cleanpro SUPPLY, 1 US gallon…

    Chemical Contamination: FDA testing found Presence of methanol

    FDA · DrugJarman's Midwest Cleaning Systems, Inc.Nationwide in the USAOfficial notice →
  6. US
    Drugs & medicalClass II

    Jarman's Midwest Cleaning Systems, Inc. recalls Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile Solution, Volume: 3.785 L, plastic gallon…

    CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.

    FDA · DrugJarman's Midwest Cleaning Systems, Inc.Nationwide in the USAOfficial notice →
  7. US
    Drugs & medicalClass III

    Amring Pharmaceuticals Inc recalls Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn,…

    Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

    FDA · DrugAmring Pharmaceuticals IncNationwide in the USA.Official notice →
See all drugs & medical recalls →