Reported Jul 26, 2023 · Terminated
Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle…
Sun Pharmaceutical Industries Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620
Is this the product you have?
- Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and b) 15 mL bottle (NDC # 62756-232-56), Rx only
- Distributed bySun Pharmaceutical Ind., Inc., NJ 08512
- Manufactured bySun Pharmaceutical Medicare Ltd., India
- Lot codes and dates
Lot#: a) BAC0334AExp 06/2023BAC0532AExp 11/2023 BAD0407AExp 08/2024 BAD0425AExp 08/2024b) BAC0335AExp 06/2023BAC0533AExp 10/2023BAD0148AExp 03/2024BAD0320AExp 07/2024
- Amount recalled
- 20,884 cartons
Where it was sold
- Nationwide
Why it was recalled
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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