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Drug Class II · moderate Ongoing

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

Lack of Assurance of Sterility

Recalling firmAurolab Trust
ReasonLack of Assurance of Sterility
Risk classClass II (Class II · moderate)
StatusOngoing
Report dateOct 7, 2026
InitiatedSep 17, 2026
RegionIndia
DistributionVA
Quantity25,220 bottles
Code/LotBatch# 6B093FI, Exp. 04/01/28; Batch# 6F511F1, Exp. 05/15/28
TypeVoluntary: Firm initiated
Recall numberD-0874-2026

Official source

U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗

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