Reported Oct 11, 2023 · Terminated
Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC…
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?
- Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resale. Office use only
- Lot23APR018
- Date Compounded24APR2023
- Expires on17APR2024
- In case of adverse event contactwww.fda.gov/medwatch or (800)-FDA-1088 Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852 (844) 446-6979
- Lot codes and dates
- 23APR018
- Amount recalled
- 364 bags (1 mL filled in 2 mL glass amber vials; 20 vials shipped in a bag)
Where it was sold
- Nationwide
Why it was recalled
Subpotent: Failing Test Results for Epinephrine
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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