The Recall Desk
SevereFDA (Drugs)·D-0422-2022·Announced 2022-02-02

Ophthalmic Solution Recalled for Lack of Sterility Assurance

Edge Pharma is recalling a combination ophthalmic solution (Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac) distributed nationwide due to lack of assurance of sterility. The product is used for topical eye application.

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: This recall is classified as FDA Class II. The hazard—lack of sterility assurance in a product intended for direct ocular application—carries significant risk of serious infection and potential vision-threatening complications, meeting the criteria for Severe severity despite no reported illnesses being stated in the source.

Plain-English summary

Edge Pharma, LLC is recalling Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 10%/0.25%/0.25%/0.125%, 10 mL per dropper in Multiple Dose Droptainers for topical ophthalmic use. The recall was initiated due to lack of assurance of sterility.

The affected product was manufactured by Edge Pharma, LLC in Colchester, Vermont, and distributed nationwide. The product is identified by NDC 05446-0859-03, with 40 droptainers involved in the recall. The lot code is 11-2021-02@2 with a date of 12/16/2021.

Because this is a sterile ophthalmic solution, use of a non-sterile product could introduce serious eye infections. Patients who have used this product should be aware of potential risks and consult their healthcare provider if they develop eye irritation, pain, redness, or discharge.

Consumers in possession of this product should stop using it and contact their healthcare provider or Edge Pharma, LLC for guidance on safe disposal and alternative treatments.

The recalled product

Product
Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-0859-03
Manufacturer
Edge Pharma, LLC
Category
Drug — Ophthalmic Solution
Hazard
  • sterility-assurance
  • 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)

  • 11-2021-02@2 12/16/2021

Distribution

Distributed nationwide across the United States.

Related recalls

Same category