AuroMedics Recalls Moxifloxacin Ophthalmic Solution Due to Discoloration
AuroMedics Pharma LLC is recalling Moxifloxacin Ophthalmic Solution due to market complaints of discoloration. The affected product is distributed nationwide in the U.S.
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 recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is discoloration, a cosmetic or quality defect, with no reported injuries or illnesses.
Plain-English summary
AuroMedics Pharma LLC is recalling Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle. The recall was initiated due to market complaints regarding discoloration in the product.
The affected product is distributed by Aurobindo Pharma USA, Inc., in East Windsor, NJ, and is made in India. The recall covers 100,080 bottles distributed nationwide in the U.S. The specific lots affected are CMF190008 and CMF190009 (Expiration 04/2021) and CMF190025 and CMF190026 (Expiration 06/2021). The product is identified by NDC 65862-840-03.
Consumers should check their medication for the listed lot numbers and expiration dates. If the product matches the recalled description, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- MOXIFLOXACIN (MOXIFLOXACIN)
- Brand
- MOXIFLOXACIN
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 100,080
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 (6)
- Lot #s: CMF190008
- CMF190009
- Exp. 04/2021
- CMF190025
- CMF190026
- Exp. 06/2021.
UPCs (1)
- 0365862840035
Distribution
Distributed nationwide across the United States.
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