Altaire Recalls Carboxymethylcellulose Sodium Eye Drops Due to Non-Sterility
Altaire Pharmaceuticals is recalling specific lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution because the preservative may not be effective through expiry, posing a non-sterility risk.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 per the rubric, as Class I recalls involve a reasonable probability that use of the product will cause serious adverse health consequences or death.
Plain-English summary
Altaire Pharmaceuticals, Inc. is recalling 363,746 bottles of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL). The product was sold nationwide under three brand labels: CVS pharmacy brand Lubricant Eye Drops, equate brand Lubricant Eye Drops, and up & up brand lubricant eye drops.
The recall was initiated due to non-sterility concerns. Customer complaints indicated the presence of mold in the product after use and handling. The investigation determined that the preservative used in the affected lots may not be effective through the expiration date, potentially allowing microbial growth.
Consumers should check their bottles for the following lot numbers and expiration dates: 11440 (Exp 09/13), 11441 (Exp 09/13), 12042 (Exp 01/14), 12103 (Exp 02/15), 12203 (Exp 05/15), 12207 (Exp 05/15), 12293 (Exp 08/15), 12352 (Exp 09/15), and 12356 (Exp 09/15). If the product matches these details, consumers should stop using it and contact the retailer or manufacturer for a refund or replacement.
The recalled product
- Product
- Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 1 FL OZ (30 mL) bottle, sold under the following labels: (a) CVS pharmacy brand LUBRICANT EYE DROPS FOR MILD TO MODERATE DRY EYE, Distributed by CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 053357 7 and UPC 0 50428
- Manufacturer
- Altaire Pharmaceuticals, Inc.
- Category
- Drug — Ophthalmic Solution
- Affected units
- 363,746
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 (20)
- Lot #: 11440
- Exp 09/13
- labeled for CVS
- 11441
- 12042
- Exp 01/14
- labeled for CVS and Wal-Mart
- 12103
- Exp 02/15
- labeled for Wal-Mart
- 12203
- Exp 05/15
- 12207
- 12293
- Exp 08/15
- 12352
- Exp 09/15
- labeled for CVS and Target
- and 12356
- labeled for CVS and Target.
Distribution
Distributed nationwide across the United States.
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