FDAFDA · Food and drugs·Recall number D-1498-2022
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.
Published September 14, 2022 · Recall initiated: August 22, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CIPLA
- Distributor
- Nationwide in the USA
- Lot
- Lot # DEG5BD2, Exp 07/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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