Why it was recalled
Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Product description
Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC: 71384-311-05.
Lot numbers, UPCs & expiration codes
Lot #s: 22DEC047 exp 9/16/23, 23FEB057 exp 11/24/23.
Where it was sold
Nationwide in the US
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-1094-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 10, 2023
- FDA report date
- Aug 30, 2023
- Quantity
- 2,683 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Imprimis NJOF, LLC
Original FDA data
Every field from FDA enforcement report D-1094-2023, exactly as published.
Show all FDA fields
- City
- Ledgewood
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 92848
- Address
- 1705 Route 46 Ste 6B
- Code information
- Lot #s: 22DEC047 exp 9/16/23, 23FEB057 exp 11/24/23.
- Postal code
- 07852-9720
- Report date
- Aug 30, 2023
- Product type
- Drugs
- Recall number
- D-1094-2023
- Classification
- Class III
- Recalling firm
- Imprimis NJOF, LLC
- Product quantity
- 2,683 bottles
- Termination date
- Jan 22, 2024
- Reason for recall
- Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottle, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC: 71384-311-05.
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Aug 10, 2023
- Center classification date
- Aug 21, 2023