Edge Pharma Recalls Epinephrine/Lidocaine Ophthalmic Solution Due to Labeling Errors
Edge Pharma, LLC is recalling 60 syringes of Epinephrine/Lidocaine HCl sterile ophthalmic solution for injection due to incorrect or missing lot and expiration dates.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is limited to labeling errors (missing/incorrect lot and expiration dates) without reported injuries.
Plain-English summary
Edge Pharma, LLC is recalling 60 syringes of Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx only. The product is identified by NDC 05446-0863-01. The recall is limited to Lot # 10-2020-13@8 with an expiration date of 12/03/2020.
The recall was initiated because the product has incorrect or missing lot and/or expiration date labeling. This is a Class III recall, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected product was distributed only in Pennsylvania. Healthcare providers and patients who have this specific product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL per syringe, Single Use Syringe, 0.025%/0.75%, Rx only, Edge Pharma LLC 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 60
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 (2)
- Lot #: 10-2020-13@8
- exp. date 12/03/2020
Distribution
Distributed in 1 state:
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