FDA-Drug2026-09-30Class IIPROCESSING DEFECT

Reliable-1 Laboratories Sodium Chloride 5% eye solution recalled for sterility assurance

OTHERNationwide distributionDrugs

What this means

Reliable-1 Laboratories is recalling Sodium Chloride Hypertonicity Ophthalmic Solution 5% (0.5 FL OZ bottles) because the manufacturer cannot assure the product was manufactured under sterile conditions. The affected lots are #3192 (expires 01/31/2027), #3293 (expires 06/30/2027), and #3336 (expires 06/30/2027). No injuries have been reported.

  • Check if you have this product by looking for the lot numbers listed above on your bottle.
  • Stop using the product if you have it.
  • Contact Reliable-1 Laboratories or your pharmacy for a replacement or refund.
  • If you have used this product and have concerns, contact your eye care provider.
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The agency's original wording
Hazard

Lack of Assurance of Sterility

Intended for
Adults
Illnesses reported
None reported
Sold states
USA Nationwide
Affected count
11083 bottles
Manufactured in
109 S 2nd St, Dupo, IL, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0856-2026

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