Why it was recalled
cGMP deviation: discontinue of stability support for product.
Product description
Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 30534, NDC 72189-0334-05
Lot numbers, UPCs & expiration codes
Lot #: 07MA2232, Exp. 4/30/23
Where it was sold
FL
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-0101-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 2, 2022
- FDA report date
- Jan 18, 2023
- Quantity
- 11 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Direct Rx
Original FDA data
Every field from FDA enforcement report D-0101-2023, exactly as published.
Show all FDA fields
- City
- Dawsonville
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 91114
- Address
- 94 Worldwide Dr
- Code information
- Lot #: 07MA2232, Exp. 4/30/23
- Postal code
- 30534-6828
- Report date
- Jan 18, 2023
- Product type
- Drugs
- Recall number
- D-0101-2023
- Classification
- Class II
- Recalling firm
- Direct Rx
- Product quantity
- 11 bottles
- Termination date
- Sep 30, 2024
- Reason for recall
- cGMP deviation: discontinue of stability support for product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 30534, NDC 72189-0334-05
- Distribution pattern
- FL
- Recall initiation date
- Nov 2, 2022
- Initial firm notification
- Letter
- Center classification date
- Jan 11, 2023