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.
Reason for recall: Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Recall initiated: 20230705
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated