FDAFDA · Food and drugs·Recall number D-0326-2022
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.
Published January 12, 2022 · Recall initiated: December 22, 2021
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
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Distributor
- Nationwide in the USA and Puerto Rico
- Lot
- Lot #: H003037, exp. date May 2022; H100132, exp. date June 2022; H100847, exp. date October 2022
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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