Drugs & medicalClass II

RemedyRepack Inc. recalls Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx…

CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.

Read the official notice →
Date
2025-01-01
Country
United States
Brand
RemedyRepack
Product
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx…
Classification
Class II
Units
Nationwide in the US
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 Details may be shortened or out of date; the official notice is the authoritative source.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 RemedyRepack recalls

  1. 2025-05-14
  2. US
    Drugs & medicalClass II

    RemedyRePack Inc. recalls Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#:…

    CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.

    FDA · DrugRemedyRePack Inc.Within U.S - PA, VA, FL.Official notice →
  3. 2025-04-30
  4. US
  5. 2025-02-12
  6. US
    Drugs & medicalClass II

    RemedyRepack Inc. recalls Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged…

    CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.

    FDA · DrugRemedyRepack Inc.FLOfficial notice →
  7. 2024-07-24
  8. US
  9. 2024-06-19
  10. US
    Drugs & medicalClass II

    RemedyRepack Inc. recalls Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source…

    Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

    FDA · DrugRemedyRepack Inc.Product was distributed to one medical facility.Official notice →
  11. 2024-05-15
  12. US
    Drugs & medicalClass II

    RemedyRepack Inc. recalls TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a)…

    Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol

    FDA · DrugRemedyRepack Inc.Nationwide in the USAOfficial notice →
All 17 RemedyRepack recalls →

Other drugs & medical recalls in the United States

  1. 2025-01-01
  2. US
    Drugs & medicalClass I

    Nova Biomedical Corporation recalls StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for…

    A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user…

    FDA · DeviceNova Biomedical CorporationDistribution US Nationwide including Puerto Rico, Germany, Italy, Israel,…Official notice →
  3. US
    Drugs & medicalClass I

    Nova Biomedical Corporation recalls StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.

    A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's data management system (DMS) at healthcare sites using…

    FDA · DeviceNova Biomedical CorporationDistribution US Nationwide including Puerto Rico, Germany, Italy, Israel,…Official notice →
  4. US
    Drugs & medicalClass II

    MXBBB recalls UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323

    cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product…

    FDA · DrugMXBBBProduct was sold via Amazon Marketplace.Official notice →
  5. US
    Drugs & medicalClass II

    Curium US, LLC recalls Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each…

    Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product

    FDA · DrugCurium US, LLCNationwide USA and Canada.Official notice →
  6. US
    Drugs & medicalClass II

    PD-Rx Pharmaceuticals, Inc. recalls DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90

    CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit

    FDA · DrugPD-Rx Pharmaceuticals, Inc.Distributed within US: FL, MS, WIOfficial notice →
  7. US
    Drugs & medicalClass II

    Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical…

    CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

    FDA · DrugBreckenridge Pharmaceutical, IncNationwide in the USOfficial notice →
See all drugs & medical recalls →