Drugs & medicalClass III

Teva Pharmaceuticals USA Inc recalls Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories,…

Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.

Read the official notice →
Date
2022-08-17
Country
United States
Brand
Teva Pharmaceuticals
Product
Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC…
Classification
Class III
Units
Distributed in Ohio
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Teva Pharmaceuticals recalls

  1. 2023-03-15
  2. US
    Drugs & medicalClass II

    Teva Pharmaceuticals USA Inc recalls Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL,…

    CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

    FDA · DrugTeva Pharmaceuticals USA IncCAOfficial notice →
  3. 2022-09-21
  4. US
    Drugs & medicalClass II

    Teva Pharmaceuticals USA Inc recalls Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a…

    Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.

    FDA · DrugTeva Pharmaceuticals USA IncNationwide in the US.Official notice →
  5. 2022-09-07
  6. US
    Drugs & medicalClass II

    Teva Pharmaceuticals USA Inc recalls Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA…

    CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.

    FDA · DrugTeva Pharmaceuticals USA IncNationwide within the United StatesOfficial notice →
  7. 2022-08-10
  8. US
    Drugs & medicalClass II

    Teva Pharmaceuticals USA Inc recalls Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavis…

    Failed Dissolution Specifications: below specification limits for dissolution.

    FDA · DrugTeva Pharmaceuticals USA IncNationwide in the USA and Puerto RicoOfficial notice →
  9. 2022-08-03
  10. US
    Drugs & medicalClass II

    Teva Pharmaceuticals USA Inc recalls Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by:…

    Superpotent Drug: Out of specification assay result was obtained during stability testing.

    FDA · DrugTeva Pharmaceuticals USA IncNationwide in the USAOfficial notice →
  11. 2022-06-29
  12. US
    Drugs & medicalClass II

    Teva Pharmaceuticals USA Inc recalls Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.

    Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.

    FDA · DrugTeva Pharmaceuticals USA IncNationwide in the U.S.Official notice →
All 44 Teva Pharmaceuticals recalls →

Other drugs & medical recalls in the United States

  1. 2022-08-17
  2. US
    Drugs & medicalClass II

    Guangdong Haiou Medical Apparatus Co., Ltd recalls Haiou Needle Retractable Safety Syringe with Needle-1ML 23G x 1 (0.6x25mm). 200pcs/Box Intended Use: Disposable…

    Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per intended use, resulting in an increased risk of needle stick…

    FDA · DeviceGuangdong Haiou Medical Apparatus Co., LtdUS Nationwide distribution in the state of CA.Official notice →
  3. US
    Drugs & medicalClass I

    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b.…

    There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy…

    FDA · DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Worldwide DistributionOfficial notice →
  4. US
    Drugs & medicalClass I

    Haimen Shengbang Laboratory Equipment Co. Ltd. recalls HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type

    Distributed VTM outside of VTM Guidance and without clearance.

    FDA · DeviceHaimen Shengbang Laboratory Equipment Co. Ltd.Worldwide distribution - US Nationwide distribution in the states of CA, FL,…Official notice →
  5. US
  6. US
    Drugs & medicalClass II

    Strides Pharma Inc. recalls Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 562106, India,…

    Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets

    FDA · DrugStrides Pharma Inc.US NationwideOfficial notice →
  7. 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 →
See all drugs & medical recalls →