Recall: D-0924-2023

Class III - Minor Violations

Class IIIClassification

2023-07-05Initiated

TerminatedStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

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

Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.

Distribution

USA nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.