Drugs & medicalClass II

The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680,…

an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.

Read the official notice →
Date
2024-02-21
Country
United States
Brand
Harvard Drug Group LLC dba Major Pharmaceuticals and…
Product
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage…
Classification
Class II
Units
The product was distributed nationwide within the United States.
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls

  1. 2024-11-27
  2. US
    Drugs & medicalClass II

    The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive,…

    Failed Impurity/Degradation Specifications

    FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide within the United StatesOfficial notice →
  3. 2024-11-20
  4. US
    Drugs & medicalClass III

    The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet…

    Failed Impurities/Degradation Specifications; during routine stability testing for impurities.

    FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide in the US.Official notice →
  5. 2024-07-10
  6. US
    Drugs & medicalClass II

    The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton,…

    Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.

    FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide. No foreign consignees.Official notice →
  7. 2023-12-27
  8. US
    Drugs & medicalClass I

    The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC…

    Failed Content Uniformity Specifications

    FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide in the USAOfficial notice →
  9. 2023-11-29
  10. US
    Drugs & medicalClass I

    The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY…

    Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.

    FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide within the United StatesOfficial notice →
  11. 2023-06-28
  12. US
    Drugs & medicalClass I

    The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's…

    Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.

    FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide in the USAOfficial notice →
All 15 Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls →

Other drugs & medical recalls in the United States

  1. 2024-02-21
  2. US
    Drugs & medicalClass I

    Abiomed, Inc. recalls Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella…

    IFU has been updated to include warnings about the risk of the inlet perforating through the myocardial wall of the left ventricle due to operator handling.

    FDA · DeviceAbiomed, Inc.Worldwide distribution - US Nationwide and the countries of AU, CA, DE, FR,…Official notice →
  3. US
    Drugs & medicalClass I

    Wipro GE Healthcare Private Ltd. recalls GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus…

    GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed…

    FDA · DeviceWipro GE Healthcare Private Ltd.Worldwide distribution.Official notice →
  4. US
    Drugs & medicalClass II

    IntegraDose Compounding Services LLC recalls Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx…

    Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.

    FDA · DrugIntegraDose Compounding Services LLCMNOfficial notice →
  5. US
    Drugs & medicalClass III

    Teva Pharmaceuticals USA, Inc recalls Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each…

    Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

    FDA · DrugTeva Pharmaceuticals USA, IncnationwideOfficial notice →
  6. 2024-02-14
  7. US
    Drugs & medicalClass II

    PHILIPS MEDICAL SYSTEMS recalls Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.

    A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

    FDA · DevicePHILIPS MEDICAL SYSTEMSWorldwide - US Nationwide distribution in the states of AR, AZ, GA, HI, IN,…Official notice →
  8. US
    Drugs & medicalClass II

    Maquet Medical Systems USA recalls Bubble Sensor (REF: 70105.5720)

    The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.

    FDA · DeviceMaquet Medical Systems USAAZ, CA, CO, FL, GA, IA, IL, MN, NE, PA, TX, WA and WI.Official notice →
See all drugs & medical recalls →