Recalls / Class III
Class IIID-0789-2020
Product
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.
- Brand name
- Moxifloxacin
- Generic name
- Moxifloxacin
- Active ingredient
- Moxifloxacin Hydrochloride
- Route
- Ophthalmic
- NDC
- 65862-840
- FDA application
- ANDA206242
- Affected lot / code info
- Lot #s: CMF190008; CMF190009, Exp. 04/2021; CMF190025; CMF190026, Exp. 06/2021.
Why it was recalled
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Manufacturer
- Aurobindo Pharma Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 100,080 bottles
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2019-12-02
- FDA classified
- 2020-01-17
- Posted by FDA
- 2020-01-22
- Terminated
- 2022-11-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0789-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.