Focus Pi For Solution
FDA Recall NDC 82724-007
Latest: Class II · Status: Ongoing · Initiated Sep 17, 2026 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Focus Pi (NDC 82724-007). A significant event, classified as Class II, was initiated on Sep 17, 2026 by Covalent Medical. The reported reason for this action was: "Lack of Assurance of Sterility"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Lack of Assurance of Sterility
Sep 17, 2026
Oct 07, 2026
25,220 bottles
Recall Profile & Regulatory Data
Event ID
99903
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Aurolab Trust
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
VA
Product Description
FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for: Covalent Management, Inc., Manassas, VA 20109. NDC: 82724-007-19
Batch or Lot Expiration Information
Batch# 6B093FI, Exp. 04/01/28
Batch# 6F511F1, Exp. 05/15/28
Affected Packages Involved in this Recall
82724-007-19Focus Pi
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.
