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.
Reported: September 14, 2022 Initiated: August 22, 2022 #D-1499-2022
Product Description
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.
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.
Details
- Recalling Firm
- CIPLA
- Units Affected
- 117,844 bottles
- Distribution
- Nationwide in the USA
- Location
- Warren, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by CIPLA. Units affected: 117,844 bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 14, 2022. Severity: Moderate. Recall number: D-1499-2022.
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