The Recall Desk
SevereFDA (Drugs)·D-0402-2022·Announced 2022-02-02

Epinephrine/Lidocaine Ophthalmic Injection Syringe Recall for Sterility Assurance

Edge Pharma is recalling Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection due to lack of assurance of sterility. The recall affects 2,568 single-use syringes distributed nationwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. A sterility defect in an intraocular injection product represents a significant potential for serious harm, as contamination could cause sight-threatening intraocular infections. Although no illnesses or injuries are reported in the source text, the inherent risk of a non-sterile injectable drug intended for the eye warrants a Severe classification under the Class II criterion.

Plain-English summary

Edge Pharma, LLC is recalling Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe. The product is intended for intraocular injection and is supplied in single-use syringes.

The recall is being conducted due to lack of assurance of sterility. The affected product was distributed nationwide. A total of 2,568 syringes have been recalled under lot codes 10-2021-18@4 (dated 12/08/2021) and 11-2021-01@3 (dated 12/22/2021).

Patients or healthcare providers who have received or used this product should contact Edge Pharma, LLC or their healthcare provider for further guidance. The product should not be used.

The recalled product

Product
Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01
Manufacturer
Edge Pharma, LLC
Category
Drug — Sterile Injectable - Ophthalmic
Hazard
  • lack-of-sterility
  • contamination-risk
  • intraocular-infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 10-2021-18@4 12/08/2021& 11-2021-01@3 12/22/2021

Distribution

Distributed nationwide across the United States.

Related recalls

Same category