FDA recall D-1498-2022

Product

Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.

Reason for recall

Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2022-08-22

Report date

2022-09-14

Termination date

2023-11-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warren, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1498-2022