Why it was recalled
Lack of Assurance of Sterility
Product description
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ NDC 71384-310-05
Lot numbers, UPCs & expiration codes
Lot: 23NOV018 Exp. 6/17/24
Where it was sold
US Nationwide
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-0548-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 14, 2024
- FDA report date
- Jun 19, 2024
- Quantity
- 4,280 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Imprimis NJOF, LLC
Original FDA data
Every field from FDA enforcement report D-0548-2024, exactly as published.
Show all FDA fields
- City
- Ledgewood
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94552
- Address
- 1705 Route 46 Ste 6B
- Code information
- Lot: 23NOV018 Exp. 6/17/24
- Postal code
- 07852-9720
- Report date
- Jun 19, 2024
- Product type
- Drugs
- Recall number
- D-0548-2024
- Classification
- Class II
- Recalling firm
- Imprimis NJOF, LLC
- Product quantity
- 4,280 boxes
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ NDC 71384-310-05
- Distribution pattern
- US Nationwide
- Recall initiation date
- May 14, 2024
- Center classification date
- Jun 7, 2024