CIPLA 2022-09-14 Health serious FDA
Health · FDA · Recall #FDA-D-1498-2022
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan… Recall
Issued September 14, 2022 · CIPLA
In September 2022, CIPLA recalled the Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact CIPLA to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- CIPLA
- Category
- Health
- Recall date
- September 14, 2022
- Units affected
- Not reported
- Sold at
- Nationwide in the USA
- Recall number
- FDA-D-1498-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- CIPLA has 3 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.