Recalls / Class II
Class IID-0560-2022
Product
Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx 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#: CMF210001, CMF210003, CMF210004, Exp 6/2023
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- Aurobindo Pharma Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 115776 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2022-01-14
- FDA classified
- 2022-02-14
- Posted by FDA
- 2022-02-23
- Terminated
- 2024-07-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0560-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.