D-0501-2026 Class II Ongoing
FDA drug recall D-0501-2026 was initiated by Thea Pharma, Inc. on April 23, 2026 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. The recall status is ongoing.
Recall Details
- Product Type
- Drugs
- Report Date
- May 6, 2026
- Initiation Date
- April 23, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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
Reason for Recall
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Distribution Pattern
Nationwide within the United States
Code Information
Lot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026.