Status
Ongoing
Drug Enforcement D-0305-2025
Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Classification
Class III
Report Date
April 9, 2025
Termination Date
—
Product Information
- Product description
- Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5 mL fill in 15 mL bottle, Imprimis NJOF, LLC, Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC: 71384-733-05.
- Product quantity
- 2822 bottles
- Reason for recall
- Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
- Recall initiation reason
- —
- Initial firm notification
- —
- Distribution pattern
- FL and NY
Location & Firm
- Recalling firm
- Imprimis NJOF, LLC
- Address
-
1705 Route 46 Ste 6B
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0305-2025
- Event ID
- 96329
- Recall initiation date
- February 24, 2025
- Center classification date
- March 28, 2025
- Code info
- Lot 24OCT041, Exp 04/26/2025
- More code info
- —