Why it was recalled
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
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.
Lot numbers, UPCs & expiration codes
Lot #s: CMF190008; CMF190009, Exp. 04/2021; CMF190025; CMF190026, Exp. 06/2021.
Where it was sold
Nationwide in the U.S.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0789-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 2, 2019
- FDA report date
- Jan 22, 2020
- Quantity
- 100,080 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AuroMedics Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0789-2020, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84498
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #s: CMF190008; CMF190009, Exp. 04/2021; CMF190025; CMF190026, Exp. 06/2021.
- Postal code
- 08520-1401
- Report date
- Jan 22, 2020
- Product type
- Drugs
- Recall number
- D-0789-2020
- Classification
- Class III
- Recalling firm
- AuroMedics Pharma LLC
- Product quantity
- 100,080 bottles
- Termination date
- Nov 22, 2022
- Reason for recall
- Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Dec 2, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 17, 2020