Recalls / Class III
Class IIID-0043-2024
Product
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% - 0.5%, 5mL bottle, Imprimis, NJOF, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852 (844)-446-6979, NDC:71384-632-05
- Affected lot / code info
- Lot#s: 22DEC065 (MDU), exp: 09/29/2023; 23JAN024 (MDU), exp: 10/13/2023; 23FEB024 (SDU), exp: 11/09/2023; 23MAR013 (SDU), exp: 12/01/2023; 23MAR033 (SDU), exp: 12/16/2023; 23MAY044 (SDU), exp: 03/23/2024;
Why it was recalled
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Recalling firm
- Firm
- Imprimis NJOF, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1705 Route 46 Ste 6B, N/A, Ledgewood, New Jersey 07852-9720
Distribution
- Quantity
- 6,228 bags + 15,360 boxes
- Distribution pattern
- Product was distributed to physician's offices nationwide.
Timeline
- Recall initiated
- 2023-09-20
- FDA classified
- 2023-10-13
- Posted by FDA
- 2023-10-25
- Terminated
- 2025-07-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0043-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.