Drugs & medicalClass II

Ascend Laboratories, LLC recalls Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend…

Failed Dissolution Specifications

Read the official notice →
Date
2023-07-26
Country
United States
Brand
Ascend Laboratories
Product
Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend…
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2024-02-28
  2. US
    Drugs & medicalClass II

    Ascend Laboratories, LLC recalls Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by:…

    Failed Impurities/Degradation Specification: Out of specification for organic impurities

    FDA · DrugAscend Laboratories, LLCNationwide in the USAOfficial notice →
  3. 2024-01-24
  4. 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 →
  5. 2023-09-13
  6. 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 →
  7. 2023-04-26
  8. US
    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.

    FDA · DrugAscend Laboratories, LLCNationwide in the USAOfficial notice →
  9. 2023-04-05
  10. 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 →
  11. 2023-02-01
  12. US
All 24 Ascend Laboratories recalls →

Other drugs & medical recalls in the United States

  1. 2023-07-26
  2. US
    Drugs & medicalClass II

    Glenmark Therapeutics, Inc. recalls Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430,…

    Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.

    FDA · DrugGlenmark Therapeutics, Inc.Nationwide in the USAOfficial notice →
  3. US
  4. US
    Drugs & medicalClass II

    New England Life Care, Inc. dba Advanced Compounding… recalls Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only,…

    CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

    FDA · DrugNew England Life Care, Inc. dba Advanced Compounding…Nationwide in the USAOfficial notice →
  5. US
    Drugs & medicalClass III

    SUN PHARMACEUTICAL INDUSTRIES INC recalls Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC#…

    Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.

    FDA · DrugSUN PHARMACEUTICAL INDUSTRIES INCUSA nationwide.Official notice →
  6. US
    Drugs & medicalClass II

    Dr Reddy's Laboratories Limited recalls Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409…

    Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.

    FDA · DrugDr Reddy's Laboratories LimitedNationwide in the USAOfficial notice →
  7. 2023-07-19
  8. US
    Drugs & medicalClass II

    HeartSine Technologies Ltd recalls HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access…

    Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator from analyzing patient condition or delivering therapy correctly.

    FDA · DeviceHeartSine Technologies LtdWorldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CT, FL, GA, HI,…Official notice →
See all drugs & medical recalls →