Sterling Pharmaceutical Recalls Lubricating Tears Due to Sterility Concerns
Sterling Pharmaceutical Services LLC is recalling specific lots of Lubricating Tears because the company cannot guarantee the product is sterile.
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 source text identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving sterility assurance issues for ophthalmic products.
Plain-English summary
Sterling Pharmaceutical Services LLC is voluntarily recalling 47,616 bottles of Lubricating Tears (Carboxymethylcellulose Sodium 0.5% Solution). The recall is being conducted because the company lacks assurance that the product is sterile. The affected product is distributed by Reliable-1 Laboratories LLC and is available in 0.5 FL OZ (15 mL) bottles.
The recall covers four specific lots: Lot # 3171 (Expiration Date 09/30/2026), Lot # 3174 (Expiration Date 10/31/2026), Lot #3275 (Expiration Date 06/30/2027), and Lot #3304 (Expiration Date 07/31/2027). The product was distributed nationwide in the United States.
Consumers who have purchased these specific lots should stop using the product and contact their healthcare provider or the recalling firm for further instructions. 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.
The recalled product
- Product
- LUBRICATING TEARS (CARBOXYMETHYLCELLULOSE SODIUM 0.5% SOLUTION)
- Brand
- LUBRICATING TEARS
- Manufacturer
- Sterling Pharmaceutical Services LLC
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 47,616
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 (8)
- Lot # 3171
- Expiration Date 09/30/2026. Lot # 3174
- Expiration Date 10/31/2026
- Lot #3275
- Expiration Date
- 06/30/2027
- Lot #3304
- Expiration date 07/31/2027.
Distribution
Distributed nationwide across the United States.
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