Drugs & medicalClass II

Glenmark Pharmaceuticals Inc., USA recalls Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC…

Failed Dissolution Specifications: results below specifications

Read the official notice →
Date
2024-07-24
Country
United States
Brand
Glenmark Pharmaceuticals
Product
Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only,…
Classification
Class II
Units
USA Nationwide
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Glenmark Pharmaceuticals recalls

  1. 2024-10-02
  2. US
    Drugs & medicalClass II

    Glenmark Pharmaceuticals Inc., USA recalls Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513,…

    Subpotent Drug

    FDA · DrugGlenmark Pharmaceuticals Inc., USAProduct was distributed nationwide within the United States.Official notice →
  3. 2024-09-04
  4. US
    Drugs & medicalClass II

    Glenmark Pharmaceuticals Inc., USA recalls Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle…

    Failed Dissolution Specifications: below specification results

    FDA · DrugGlenmark Pharmaceuticals Inc., USANationwide USAOfficial notice →
  5. 2024-08-07
  6. US
  7. 2024-07-24
  8. US
  9. US
  10. 2024-06-12
  11. US
    Drugs & medicalClass II

    Glenmark Pharmaceuticals Inc., USA recalls Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark…

    CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

    FDA · DrugGlenmark Pharmaceuticals Inc., USAUS Nationwide.Official notice →
All 43 Glenmark Pharmaceuticals recalls →

Other drugs & medical recalls in the United States

  1. 2024-07-24
  2. US
    Drugs & medicalClass II

    St. Jude Medical recalls St. Jude Medical Agilis NxT Steerable Introducer, REF 408309

    One lot of product has dilators that are too short and will not extend outside the introducer sheath.

    FDA · DeviceSt. Jude MedicalUS and CanadaOfficial notice →
  3. US
    Drugs & medicalClass I

    Baxter Healthcare Corporation recalls Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent…

    Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.

    FDA · DeviceBaxter Healthcare CorporationNationwide distribution. International distribution to Canada, France, and…Official notice →
  4. US
    Drugs & medicalClass I

    Abiomed, Inc. recalls Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump

    Nine (9) Impella CP pumps failed inspection and were inadvertently released.

    FDA · DeviceAbiomed, Inc.Domestic only: FL, MA, OH TX.Official notice →
  5. US
  6. US
    Drugs & medicalClass II

    Homeocare Laboratories, Inc. recalls STELLALIFE ADVANCED FORMULA Peppermint, VEGA Oral Care, Rinse, 16 fl oz (473 ml), Distributed by: StellaLife, 2875 NE 191 Street,…

    Microbial Contamination of Non-Sterile Products: presence of Terribacillus species organism

    FDA · DrugHomeocare Laboratories, Inc.Nationwide to 60 Physician officesOfficial notice →
  7. US
    Drugs & medicalClass I

    Homeocare Laboratories, Inc. recalls STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street, Suite 500,…

    Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms

    FDA · DrugHomeocare Laboratories, Inc.Nationwide to 60 Physician officesOfficial notice →
See all drugs & medical recalls →