Class II · Moderate risk
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
Lack of Assurance of Sterility
Reliable -1 Laboratories
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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.
Affected NDC
69618-0077-55
Compare with the code on your package — it is the most precise check available.
Category: Eye Drops & Ophthalmic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Sodium Chloride Hypertonicity Ophthalmic Solution, 5% NDC 69618-0077 |
SODIUM CHLORIDE 50 mg/mL | Solution/ Drops Ophthalmic |
Reliable 1 Laboritories LLC | OTC |
- Recalling firm
- Sterling Pharmaceutical Services LLC
- NDC code
- 69618-077-55
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0856-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
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Class II · Moderate risk
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
Lack of Assurance of Sterility
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