Drugs & medicalClass II

Direct Rx recalls CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.

Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

Read the official notice →
Date
2025-04-23
Country
United States
Brand
Direct Rx
Product
CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle, Rx Only, Generic for CILOXAN, Packaged and Distributed by: DIRECT Rx, NDC 61919-795-05.
Classification
Class II
Units
Physicians and medical facilities in 5 states: AL, CA, FL, GA, ID
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Direct Rx recalls

  1. 2026-07-01
  2. US
    Drugs & medicalClass II

    Direct Rx recalls DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.

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

    FDA · DrugDirect RxU.S. NationwideOfficial notice →
  3. 2025-08-13
  4. US
    Drugs & medicalClass II

    Direct Rx recalls Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc.,…

    CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

    FDA · DrugDirect RxNationwideOfficial notice →
  5. 2024-11-13
  6. US
    Drugs & medicalClass II

    Direct Rx recalls Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA…

    Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.

    FDA · DrugDirect RxNationwide in the USOfficial notice →
  7. 2023-04-12
  8. US
    Drugs & medicalClass II

    Direct Rx recalls Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and…

    CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

    FDA · DrugDirect RxNationwide in the USAOfficial notice →
  9. 2023-04-05
  10. US
  11. 2023-01-18
  12. US
All 14 Direct Rx recalls →

Other drugs & medical recalls in the United States

  1. 2025-04-23
  2. US
    Drugs & medicalClass I

    Bard Access Systems, Inc. recalls BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955,…

    Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to…

    FDA · DeviceBard Access Systems, Inc.Worldwide - US Nationwide distribution including in the states of WI, NC, TX,…Official notice →
  3. US
    Drugs & medicalClass II

    The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only,…

    CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

    FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide USAOfficial notice →
  4. US
    Drugs & medicalClass I

    Dr. Reddy's Laboratories, Inc. recalls Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma…

    LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam…

    FDA · DrugDr. Reddy's Laboratories, Inc.Nationwide in the USAOfficial notice →
  5. US
    Drugs & medicalClass II

    Eugia US LLC recalls Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Single-Dose Vial, Distributed by Eugia US LLC, E. Windsor, NJ,…

    cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.

    FDA · DrugEugia US LLCNationwide USAOfficial notice →
  6. US
    Drugs & medicalClass II

    Chattem Inc recalls Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219,…

    CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit

    FDA · DrugChattem IncNationwide.Official notice →
  7. 2025-04-16
  8. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.

    Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.Domestic: Nationwide Distribution. International: Australia, Austria, Bahamas,…Official notice →
See all drugs & medical recalls →