Class III
Terminated
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.
This recall has been terminated (originally issued July 26, 2023).
- Recall Initiated
- July 5, 2023
- Posted
- July 26, 2023
- Recall Number
- D-0924-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 20,884 cartons
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Distribution
USA nationwide.
Lot / Code Info
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
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