Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03.
Reported: January 22, 2020 Initiated: December 2, 2019 #D-0789-2020
Product Description
Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03.
Reason for Recall
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Details
- Recalling Firm
- AuroMedics Pharma LLC
- Units Affected
- 100,080 bottles
- Distribution
- Nationwide in the U.S.
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03.. Recalled by AuroMedics Pharma LLC. Units affected: 100,080 bottles.
Why was this product recalled? ▼
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 22, 2020. Severity: Low. Recall number: D-0789-2020.
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