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.
Reported: January 12, 2022 Initiated: December 22, 2021 #D-0326-2022
Product Description
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.
Reason for Recall
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 50,832 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 50,832 bottles.
Why was this product recalled? ▼
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 12, 2022. Severity: Low. Recall number: D-0326-2022.
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