Eye Drops Recalled for Lack of Sterility Assurance by Edge Pharma
Edge Pharma is recalling a multi-ingredient sterile ophthalmic solution nationwide due to lack of assured 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: The FDA classified this as a Class II recall. A sterile pharmaceutical product lacking sterility assurance presents a significant risk of infection when applied directly to the eye, a sensitive tissue, potentially requiring medical intervention.
Plain-English summary
Edge Pharma, LLC is recalling Phenylephrine HCl / Tropicamide / Ciprofloxacin / Ketorolac Sterile Ophthalmic Solution (10%/1%/0.3%/0.125%, 0.8 mL per syringe, single-use syringe, for topical ophthalmic use) with NDC 05446-1270-01 due to lack of assurance of sterility.
The recalled product was distributed nationwide. Affected lots are 08-2021-31@8 (expiration date 12/21/2021) and 10-2021-13@1 (expiration date 01/19/2022). A total of 2,463 vials have been recalled.
Patients currently using this product should contact their healthcare provider or pharmacist. Those who have received or used the recalled product should consult their eye care professional to determine if they may have been affected.
The recalled product
- Product
- Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%, 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1270-01
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Ophthalmic Solution
- Affected units
- 2,463
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)
- 08-2021-31@8 12/21/2021 & 10-2021-13@1 01/19/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 recalled by Edge Pharma, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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