FDAFDA · Food and drugs·Recall number 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 by: Sun Pharmaceutical Ind., Inc., NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Ltd., India.
Published July 26, 2023 · Recall initiated: July 5, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- LOTEPREDNOL ETABONATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- USA nationwide.
- UPC
- 0362756232907
- Lot
- Lot#: a) BAC0334A, Exp 06/2023; BAC0532A, Exp 11/2023 BAD0407A, Exp 08/2024 BAD0425A, Exp 08/2024; b) BAC0335A, Exp 06/2023, BAC0533A, Exp 10/2023, BAD0148A, Exp 03/2024, BAD0320A, Exp 07/2024
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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