Reported Oct 25, 2023 · Terminated
MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5%…
Imprimis NJOF, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Imprimis NJOF, LLC · 1705 Route 46 Ste 6B · Ledgewood, NJ · 07852-9720
Is this the product you have?
- MYDRIATIC-4Tropicamide - 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
- NDC71384-632-05
- Lot codes and dates
- Lot#s: 22DEC065 (MDU)
- exp
09/29/202323JAN024 (MDU)
- exp
10/13/202323FEB024 (SDU)
- exp
11/09/202323MAR013 (SDU)
- exp
12/01/202323MAR033 (SDU)
- exp
12/16/202323MAY044 (SDU)
- exp03/23/2024
- Amount recalled
- 6,228 bags + 15,360 boxes
Where it was sold
- Nationwide
Why it was recalled
Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Imprimis NJOF, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.