Why it was recalled
Lack of Assurance of Sterility
Product description
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-509-08
Lot numbers, UPCs & expiration codes
Lot #: 23OCT013, Exp. Date 10/10/2024
Where it was sold
Nationwide within the United States
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-0515-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 14, 2024
- FDA report date
- Jun 5, 2024
- Quantity
- 18,980 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Imprimis NJOF, LLC
Original FDA data
Every field from FDA enforcement report D-0515-2024, exactly as published.
Show all FDA fields
- City
- Ledgewood
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94551
- Address
- 1705 Route 46 Ste 6B
- Code information
- Lot #: 23OCT013, Exp. Date 10/10/2024
- Postal code
- 07852-9720
- Report date
- Jun 5, 2024
- Product type
- Drugs
- Recall number
- D-0515-2024
- Classification
- Class II
- Recalling firm
- Imprimis NJOF, LLC
- Product quantity
- 18,980 vials
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-509-08
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- May 14, 2024
- Center classification date
- May 29, 2024