Lupin Recalls Moxifloxacin Ophthalmic Solution Due to Impurity Levels
Lupin Pharmaceuticals is recalling Moxifloxacin Ophthalmic Solution because impurity levels exceeded specifications. The recall covers 674,628 bottles distributed nationwide and in Puerto Rico.
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 as a Class III recall, 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%, 3 mL bottles. The recall involves 674,628 bottles distributed nationwide in the USA and Puerto Rico. The product is a prescription ophthalmic solution manufactured by Lupin Limited in India.
The recall is an expansion of previous actions taken in July 2018 and February 2019. It is being conducted because the product failed impurities and degradation specifications, specifically due to high out-of-specification levels for impurities. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
Patients and consumers should stop using the affected product and contact their healthcare provider or pharmacist for a replacement or alternative treatment. The affected lots include specific expiration dates ranging from March 2019 to December 2020, as detailed in the recall notice.
The recalled product
- Product
- MOXIFLOXACIN (MOXIFLOXACIN)
- Brand
- MOXIFLOXACIN
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 674,628
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 (20)
- Lots: H701618
- H701619
- H701620
- Exp March 2019
- H702220
- H702221
- H702222
- H702223
- H702224
- H702225
- H702351
- Exp April 2019
- H702971
- H702972
- H702973
- H702974
- H703151
- H703152
- H703153
- Exp June 2019
UPCs (1)
- 0368180422013
Distribution
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