Class III
Terminated
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
- Company
- Imprimis Njof, Llc
- Recall Initiated
- September 20, 2023
- Posted
- October 25, 2023
- Recall Number
- D-0043-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 6,228 bags + 15,360 boxes
- Firm Location
- Ledgewood, NJ, United States
Reason for Recall
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Distribution
Product was distributed to physician's offices nationwide.
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;
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