Why it was recalled
Subpotent Drug
Product description
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08
Lot numbers, UPCs & expiration codes
Lot #: 23JUN031; Exp. 07/03/2024
Where it was sold
U.S. 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-0476-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 10, 2024
- FDA report date
- May 8, 2024
- Quantity
- 3320 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Imprimis NJOF, LLC
Original FDA data
Every field from FDA enforcement report D-0476-2024, exactly as published.
Show all FDA fields
- City
- Ledgewood
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94378
- Address
- 1705 Route 46 Ste 6B
- Code information
- Lot #: 23JUN031; Exp. 07/03/2024
- Postal code
- 07852-9720
- Report date
- May 8, 2024
- Product type
- Drugs
- Recall number
- D-0476-2024
- Classification
- Class II
- Recalling firm
- Imprimis NJOF, LLC
- Product quantity
- 3320 bottles
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Apr 10, 2024
- Initial firm notification
- Letter
- Center classification date
- Apr 29, 2024