Gatifloxacin Ophthalmic Solution recall
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
Why was Gatifloxacin Ophthalmic Solution recalled?
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: H003037, exp. date May 2022; H100132, exp. date June 2022; H100847, exp. date October 2022
- Product
- Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 50,832 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall date
- January 12, 2022
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)