FDAFDA · Food and drugs·Recall number D-1499-2022
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.
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
- Brand
- DIFLUPREDNATE
- Manufacturer
- CIPLA
- Distributor
- Nationwide in the USA
- Lot
- Lot #: DEG1HC2, DEG2HC2, DEG3HC2, DEG4HC2, DEG5HC2, DEG6HC2, Exp 01/2023; DEG1IC2, DEG2IC2, DEG3IC2, DEG4IC2, Exp 02/2023; DEG1LC2, DEG2LC2, Exp 05/2023; DEG1BD2, DEG2BD2, DEG3BD2, Exp 07/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.