Bausch & Lomb Recalls Lotemax Ophthalmic Gel for Viscosity Issues
Bausch & Lomb is recalling Lotemax ophthalmic gel because it failed stability specifications for viscosity. The recall covers 17,083 bottles distributed nationwide.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a stability specification failure (viscosity) rather than a direct safety hazard like contamination or mislabeling.
Plain-English summary
Bausch & Lomb is recalling Lotemax (loteprednol etabonate ophthalmic gel 0.5%), a prescription eye medication, because the product failed stability specifications for viscosity. The recall affects 17,083 bottles of the 5 g sterile gel, distributed nationwide in the United States.
The affected products are identified by specific lot numbers and expiration dates: Lot #s 282611, 283431, 283441, and 283451 (Exp. 10/2019); and Lot #s 282971, 282981, 283611, 283621, and 283631 (Exp. 11/2019). The product is manufactured by Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC.
Consumers should check their medication for these specific lot numbers and expiration dates. If the product matches the recalled lots, they should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or disposal. The FDA has classified this recall as Class III, indicating that use of the product is not likely to cause adverse health consequences.
The recalled product
- Product
- LOTEMAX (LOTEPREDNOL ETABONATE)
- Brand
- LOTEMAX
- Manufacturer
- Bausch & Lomb
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 170,832
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 (11)
- Lot #s: 282611
- 283431
- 283441
- 283451
- Exp. 10/2019
- 282971
- 282981
- 283611
- 283621
- 283631
- Exp. 11/2019.
Distribution
Distributed nationwide across the United States.
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