← FDA ENFORCEMENT
D-0874-2026Class II
Aurolab Trust
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Aurolab Trust
Product type
Drug
Status
Ongoing
Report date
2026-10-07
Distribution
VA
Product quantity
25,220 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason for recall
Lack of Assurance of Sterility
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
Code / lot info
Batch# 6B093FI, Exp. 04/01/28; Batch# 6F511F1, Exp. 05/15/28
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →