Mylan Recalls Gatifloxacin Ophthalmic Solution Due to Unknown Impurity
Mylan Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution 0.5% due to an out-of-specification result for an unknown impurity.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which indicates a low risk of adverse health consequences. The source text does not report any illnesses or injuries.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, NDC 0378-5431-35. The recall affects 13,157 bottles from Lot GABH0003 with an expiration date of 7/2020. The product was distributed nationwide in the USA.
The recall was initiated because the product failed impurities/degradation specifications, specifically showing an out-of-specification (OOS) result for an unknown impurity. The product is a prescription-only ophthalmic solution manufactured in India for Mylan Pharmaceuticals Inc.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC: 0378-5431-35
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
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 GABH0003
- EXP 7/2020
Distribution
Distributed nationwide across the United States.
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