Lupin Pharmaceuticals Inc. 2022-01-12 Health moderate FDA
Health · FDA · Recall #FDA-D-0326-2022
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin… Recall
Issued January 12, 2022 · Lupin Pharmaceuticals Inc.
In January 2022, Lupin Pharmaceuticals Inc. recalled the Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin…, a moderate health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
What you should do
- 1 Stop using Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Lupin Pharmaceuticals Inc. 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
- Lupin Pharmaceuticals Inc.
- Category
- Health
- Recall date
- January 12, 2022
- Units affected
- Not reported
- Sold at
- Nationwide in the USA and Puerto Rico
- Recall number
- FDA-D-0326-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Lupin Pharmaceuticals Inc. has 19 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.