Status
Terminated
Drug Enforcement D-0924-2023
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Classification
Class III
Report Date
July 26, 2023
Termination Date
February 26, 2024
Product Information
- Product description
- 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.
- Product quantity
- 20,884 cartons
- Reason for recall
- Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- USA nationwide.
Location & Firm
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Address
-
2 Independence Way, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0924-2023
- Event ID
- 92637
- Recall initiation date
- July 5, 2023
- Center classification date
- July 17, 2023
- 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
- More code info
- —