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Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservat...

FDA Recall #D-0040-2024 — Class III — October 3, 2023

Recall #D-0040-2024 Date: October 3, 2023 Classification: Class III Status: Terminated

Product Description

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. Lot: 23APR018 Date Compounded: 24APR2023 Expires on: 17APR2024. In case of adverse event contact: www.fda.gov/medwatch or (800)-FDA-1088 Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852 (844) 446-6979

Reason for Recall

Subpotent: Failing Test Results for Epinephrine

Recalling Firm

Imprimis NJOF, LLC — Ledgewood, NJ

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

364 bags (1 mL filled in 2 mL glass amber vials; 20 vials shipped in a bag)

Distribution

Nationwide

Code Information

23APR018

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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