Class III · Low risk
Loteprednol Etabonate Ophthalmic Suspension
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Lotemax (loteprednol etabonate ophthalmic gel 0.5%)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Stability Specifications: Out of specification for viscosity.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, NDC 24208-503-07.
Affected NDC
24208-0503-07
Compare with the code on your package — it is the most precise check available.
Drug: Loteprednol 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 |
|---|---|---|---|---|
| Lotemax loteprednol etabonate NDC 24208-0503 |
5 mg/g | Gel Ophthalmic |
Bausch & Lomb Incorporated | Rx |
- Recalling firm
- Bausch & Lomb
- NDC code
- 24208-503-07
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1396-2019 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Loteprednol recalls
See all
Class II · Moderate risk
Lotemax Sm
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other recalls by Bausch & Lomb
All 2019 recalls
Class II · Moderate risk
NasalCrom (cromolyn sodium)
CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Class III · Low risk
Tropicamide Ophthalmic Solution USP
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class III · Low risk
Tropicamide Ophthalmic Solution USP
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class III · Low risk
Cyclopentolate Hydrochloride Ophthalmic Solution USP
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
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