Gatifloxacin Ophthalmic Solution Recalled for Failed Stability Tests
Lupin Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution 0.5% due to failed water loss tests that may affect drug concentration. The recall affects 16,272 bottles distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall involving a stability specification failure with potential but not confirmed effect on drug concentration. No illnesses or injuries are reported in the source text, and the hazard is theoretical rather than active. Class III recalls are typically scored 1 or 2; this scores 2 due to the pharmaceutical context and potential for altered efficacy.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottles (NDC 68180-435-01, Lot # H002512, expiration date March 2022) nationwide and in Puerto Rico. The recall was issued because out-of-specification results were observed in a water loss test.
The failed water loss test may affect the assay content and alter the drug concentration in the affected bottles. Gatifloxacin is an antibiotic eye drop used to treat bacterial eye infections.
Consumers who have been dispensed this product should contact their pharmacist or healthcare provider for guidance. Healthcare providers should check their inventories and quarantine any affected product.
The recalled product
- 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.
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 16,272
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # H002512
- exp. date March 2022
Distribution
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