Lupin Recalls Moxifloxacin Ophthalmic Solution Due to Stability Test Failure
Lupin Pharmaceuticals is recalling Moxifloxacin Ophthalmic Solution because an out-of-specification result was found in a stability study. The product was distributed throughout the United States.
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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottles. The recall involves 13,896 bottles with Lot # H800393 and an expiration date of 01/2020. The product is a prescription ophthalmic solution manufactured for Lupin Pharmaceuticals Inc. in Baltimore, Maryland, and manufactured by Lupin Limited in India.
The recall was initiated due to a failed impurities/degradation specification. Specifically, an out-of-specification result was identified in the related substance test during a three-month long-term stability study. The FDA has classified this recall as Class III, indicating that use of, or exposure to, the violative product is not likely to cause adverse health consequences.
The product was distributed throughout the United States. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for further instructions or a replacement.
The recalled product
- Product
- MOXIFLOXACIN (MOXIFLOXACIN)
- Brand
- MOXIFLOXACIN
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 13,896
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 #: H800393
- Exp. 01/2020
UPCs (1)
- 0368180422013
Distribution
Distribution scope not specified by the agency.
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