FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

Direct Rx Moxifloxacin Ophthalmic Solution 0 Recall

Moxifloxacin Ophthalmic Solution USP 0

Direct Rx · Dawsonville, GA

Risk level
Class II
Reported by FDA
Mar 9, 2022
Recall ID
D-0637-2022
Check your lot numberHow we source this data

Summary

Direct Rx recalled Moxifloxacin Ophthalmic Solution 0 starting Feb 17, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0637-2022 on Mar 9, 2022. Reason: Failed impurities/degradation specifications. Status: Terminated.

Why it was recalled

Failed impurities/degradation specifications

Product description

Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 72189-076-05

Lot numbers, UPCs & expiration codes

Lot#: 18JA2218 Exp. 6/30/23; 20DE2104 Exp. 6/30/23; 08NO2111 Exp. 6/30/23

Where it was sold

Florida

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0637-2022
Classification
Class II
Status
Terminated
Recall initiated
Feb 17, 2022
FDA report date
Mar 9, 2022
Quantity
44 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Direct Rx

Original FDA data

Every field from FDA enforcement report D-0637-2022, exactly as published.

Show all FDA fields
City
Dawsonville
State
GA
Status
Terminated
Country
United States
Event ID
89642
Address
94 Worldwide Dr
Code information
Lot#: 18JA2218 Exp. 6/30/23; 20DE2104 Exp. 6/30/23; 08NO2111 Exp. 6/30/23
Postal code
30534-6828
Report date
Mar 9, 2022
Product type
Drugs
Recall number
D-0637-2022
Classification
Class II
Recalling firm
Direct Rx
Product quantity
44 bottles
Termination date
Oct 4, 2023
Reason for recall
Failed impurities/degradation specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 72189-076-05
Distribution pattern
Florida
Recall initiation date
Feb 17, 2022
Initial firm notification
Letter
Center classification date
Feb 25, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0637-2022, published Mar 9, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

Other recent drug recalls