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Recall Observatory FDA recall evidence

Drug product

Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11

D-0501-2026

April 23, 2026

Class II

Product summary

Firm
Thea Pharma, Inc.
Event
Event 98792
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0501-2026

Official wording

Reason: Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.

Code information: Lot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026.

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP deviations
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility