Recalls / Class III
Class IIID-0924-2023
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.
- Brand name
- Loteprednol Etabonate
- Generic name
- Loteprednol Etabonate
- Active ingredient
- Loteprednol Etabonate
- Route
- Ophthalmic
- NDC
- 62756-232
- FDA application
- ANDA212450
- Affected 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
Why it was recalled
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 20,884 cartons
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2023-07-05
- FDA classified
- 2023-07-17
- Posted by FDA
- 2023-07-26
- Terminated
- 2024-02-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0924-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.