AvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
Sterling Pharmaceutical Services LLC is recalling AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% 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 involves a lack of assurance of sterility in an ophthalmic product, which poses a risk of serious adverse health consequences such as infection, fitting the 'Severe' criteria for significant injury risk or Class II with potential for hospitalization.
Plain-English summary
Sterling Pharmaceutical Services LLC is recalling AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, a lubricant eye drop, due to a lack of assurance of sterility. The recall involves 12,864 packs of the 0.5 FL OZ (15 mL) sterile bottles, identified by NDC 50268-068-15. The affected lots include Lot# 3161 (Exp 8/2026), Lot# 3245 (Exp 3/2027), Lot# 3260 (Exp 5/2027), Lot# 3298, 3299, and 3300 (Exp 6/2027), and Lot# 3301, 3302, 3305, and 3306 (Exp 7/2027).
The product was distributed nationwide in the USA. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers who have purchased this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The recall is being conducted to ensure the safety of the ophthalmic solution.
The recalled product
- Product
- CARBOXYMETHYLCELLULOSE SODIUM (CARBOXYMETHYLCELLULOSE SODIUM)
- Brand
- CARBOXYMETHYLCELLULOSE SODIUM
- Manufacturer
- Sterling Pharmaceutical Services LLC
- Category
- Drug — Ophthalmic Solution
- Affected units
- 12,864
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 (14)
- Lot# 3161
- Exp 8/2026
- Lot# 3245
- Expiry: 3/2027
- Lot# 3260
- Expiry: 5/2027
- Lot# 3298
- Lot# 3299
- and Lot# 3300
- Expiry: 6/2027
- Lot# 3301
- Lot# 3302
- Lot# 3305 and Lot# 3306
- Expiry: 7/2027
Distribution
Distributed nationwide across the United States.
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