D-0856-2026 Class II Ongoing
FDA drug recall D-0856-2026 was initiated by Sterling Pharmaceutical Services LLC on Aug 20, 2026 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 11083 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 30, 2026
- Initiation Date
- Aug 20, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11083 bottles
Product Description
Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, NDC 69618-077-55.
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
USA Nationwide
Code Information
Lot #3192, Exp Date 01/312027; 3293, 3336 Exp Date 06/30/2027