Diclofenac Solution/ Drops
FDA Recall NDC 59390-149
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Diclofenac (NDC 59390-149). A significant event, classified as Class II, was initiated on Jul 02, 2019 by Altaire Pharmaceuticals Inc.. The reported reason for this action was: "Lack of Assurance of Sterility"
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
Lack of Assurance of Sterility
Jul 02, 2019
Nov 27, 2019
49527 units
Recall Profile & Regulatory Data
Event ID
83265
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Product Description
Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 59390-149-05
Batch or Lot Expiration Information
Lot# 17225 07/19 17247 08/19 18038 02/20 18162 06/20 19014 01/21
Affected Packages Involved in this Recall
59390-149-02Product
59390-149-05Product
Class II Completed
Lack of Assurance of Sterility
Jul 02, 2019
Nov 27, 2019
390 units
Recall Profile & Regulatory Data
Event ID
83265
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Altaire Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Product Description
Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 2.5 mL, Rx only, Manufactured Altaire Pharmaceuticals, NDC 59390-149-02
Batch or Lot Expiration Information
Lot# 17247 8/19
Affected Packages Involved in this Recall
59390-149-02Product
59390-149-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
