FDAFDA · Food and drugs·Recall number D-1283-2022
Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limited., L-32, 33, 34, Verna Industrial area, Verna - Goa, 403722, India; Mfd. for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-341-35.
Published July 27, 2022 · Recall initiated: July 14, 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
- Batch# DEG4LC2, exp. date 05/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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