Sodium Chloride Ophthalmic Solution Recalled for Sterility Assurance Issues
Sterling Pharmaceutical Services is recalling Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, due to a lack of assurance of sterility.
What this means for you
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an ophthalmic product, which poses a significant risk of infection.
Plain-English summary
Sterling Pharmaceutical Services LLC is recalling Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, sterile, 0.5 FL OZ (15 mL) bottles. The product is distributed by Reliable-1 Laboratories LLC in Valley Stream, NY, and carries NDC 69618-077-55.
The recall was initiated due to a lack of assurance of sterility. The affected units include 11,083 bottles distributed nationwide in the United States. Specific lots affected are Lot #3192 with an expiration date of 01/31/2027, and Lots #3293 and #3336 with an expiration date of 06/30/2027.
Consumers should stop using the product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC SOLUTION, 5% (SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC SOLUTION, 5%)
- Brand
- SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC SOLUTION, 5%
- Manufacturer
- Sterling Pharmaceutical Services LLC
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 11,083
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #3192
- Exp Date 01/312027
- 3293
- 3336 Exp Date 06/30/2027
Distribution
Distributed nationwide across the United States.
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