Drugs & medicalClass II

CIPLA recalls Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC…

Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.

Read the official notice →
Date
2022-09-14
Country
United States
Brand
Cipla
Product
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC…
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Cipla recalls

  1. 2024-05-01
  2. US
    Drugs & medicalClass II

    Cipla USA, Inc. recalls Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30…

    Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.

    FDA · DrugCipla USA, Inc.USA nationwide.Official notice →
  3. 2023-07-19
  4. US
    Drugs & medicalClass I

    Cipla USA, Inc. recalls Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured…

    Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).

    FDA · DrugCipla USA, Inc.Nationwide in the USOfficial notice →
  5. 2022-10-12
  6. US
    Drugs & medicalClass II

    CIPLA recalls Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch,…

    Lack of Assurance of Sterility: environmental monitoring failure.

    FDA · DrugCIPLAProduct was distributed nationwide to distributors/wholesalers who may have…Official notice →
  7. 2022-10-05
  8. US
  9. 2022-08-17
  10. US
    Drugs & medicalClass II

    CIPLA recalls Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured…

    Lack of Assurance of Sterility: Complaints received of defective container closure.

    FDA · DrugCIPLANationwide in the USAOfficial notice →
  11. 2022-07-27
  12. US
    Drugs & medicalClass II

    CIPLA recalls Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limited., L-32, 33, 34,…

    Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.

    FDA · DrugCIPLANationwide in the USAOfficial notice →
All 20 Cipla recalls →

Other drugs & medical recalls in the United States

  1. 2022-09-14
  2. US
    Drugs & medicalClass II

    Ortho-Clinical Diagnostics, Inc. recalls VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461

    Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer.…

    FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice →
  3. US
  4. US
    Drugs & medicalClass I

    Philips Respironics, Inc. recalls Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and…

    Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

    FDA · DevicePhilips Respironics, Inc.Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA,…Official notice →
  5. US
    Drugs & medicalClass II

    Akorn, Inc. recalls Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-711-31

    cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.

    FDA · DrugAkorn, Inc.USA nationwideOfficial notice →
  6. US
    Drugs & medicalClass II

    Plastikon Healthcare LLC recalls Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use…

    CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

    FDA · DrugPlastikon Healthcare LLCDistributed Nationwide in the USAOfficial notice →
  7. US
    Drugs & medicalClass I

    Plastikon Healthcare LLC recalls MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For…

    Microbial Contamination of Non-Sterile Products.

    FDA · DrugPlastikon Healthcare LLCDistributed Nationwide in the USAOfficial notice →
See all drugs & medical recalls →