Drugs & medicalClass II

Ascend Laboratories, LLC recalls Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by:…

Out of specification (OOS) for Spectroscopic Identification test by IR.

Read the official notice →
Date
2023-04-26
Country
United States
Brand
Ascend Laboratories
Product
Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by:…
Classification
Class II
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Ascend Laboratories recalls

  1. 2024-01-24
  2. US
    Drugs & medicalClass II

    Ascend Laboratories, LLC recalls Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA,…

    Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.

    FDA · DrugAscend Laboratories, LLCNationwideOfficial notice →
  3. 2023-09-13
  4. US
    Drugs & medicalClass III

    Ascend Laboratories, LLC recalls Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA,…

    Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.

    FDA · DrugAscend Laboratories, LLCThe recall product was distributed nationwide.Official notice →
  5. 2023-07-26
  6. US
  7. 2023-04-05
  8. US
    Drugs & medicalClass II

    Ascend Laboratories, LLC recalls Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA,…

    CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

    FDA · DrugAscend Laboratories, LLCNationwide in the USA.Official notice →
  9. 2023-02-01
  10. US
  11. 2023-01-25
  12. US
    Drugs & medicalClass II

    Ascend Laboratories, LLC recalls Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30; Manufactured by Alkem Laboratories Ltd., India;…

    Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.

    FDA · DrugAscend Laboratories, LLCCustomers in 19 states: CA, FL, GA, IL, KY, LA, MI, MN, MS, NC, NJ, NY, OH,…Official notice →
All 24 Ascend Laboratories recalls →

Other drugs & medical recalls in the United States

  1. 2023-04-26
  2. US
    Drugs & medicalClass II

    BioFire Diagnostics, LLC recalls FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)

    Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results.

    FDA · DeviceBioFire Diagnostics, LLCUS Nationwide distribution in the states of AR, CA, DC, IL, KS, LA, MN, NC,…Official notice →
  3. US
    Drugs & medicalClass II

    Pro-Dex Inc recalls KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a…

    Incorrect Unique Device Identifier/GTIN code was used on product.

    FDA · DevicePro-Dex IncU.S. Nationwide distribution in the state of FL.Official notice →
  4. US
    Drugs & medicalClass I

    Covidien recalls Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Cannula (REF,…

    A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories.…

    FDA · DeviceCovidienWorldwide - US Nationwide distribution including in the states of PR, CA, FL,…Official notice →
  5. US
  6. US
    Drugs & medicalClass II

    Pharma Nobis LLC recalls Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by: CVS Pharmacy, Inc.,…

    CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.

    FDA · DrugPharma Nobis LLCNationwide in the USAOfficial notice →
  7. US
    Drugs & medicalClass II

    Amerisource Health Services LLC recalls Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (10 x 10) per carton, Rx only, Distributed by:…

    Failed Dissolution Specifications: Out of specification dissolution results above specified values.

    FDA · DrugAmerisource Health Services LLCNationwide in the USAOfficial notice →
See all drugs & medical recalls →