Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC#
Summary
The FDA issued a Class III for Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bot by SUN PHARMACEUTICAL INDUSTRIES INC. Reason: Superpotent Drug: Out of Specification (OOS) results observed for unit dose content..
Details
Source
Drug Recall
External ID
D-0924-2023
Action Date
2023-07-26
Status
Terminated
Category
drug
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.
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
Quantity Affected: 20,884 cartons
Reason for Recall
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Distribution
USA nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-05
Company
Princeton, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 71 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
SUN PHARMACEUTICAL INDUSTRIES INC has 84 FDA actions in our database, including 83 recalls and 1 clearance.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SUN PHARMACEUTICAL INDUSTRIES INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SUN PHARMACEUTICAL INDUSTRIES INC have FDA actions?
SUN PHARMACEUTICAL INDUSTRIES INC has 84 FDA actions in our database, including 83 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0924-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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