FDARecalled Jul 26, 2023 · #D-0924-2023
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...
Hazard
Class III — low health risk
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Superpotent Drug: Out of Specification (OOS) results observed for unit dose content. Classification: Class III Distribution: USA nationwide.
Product details
- Product
- 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 by: Sun Pharmaceutical Ind., Inc., NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Ltd., India.
- Type
- Drugs
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Model numbers
- —
- UPCs
- —