Vancomycin HCl Ophthalmic Solution Recalled for Sterility Assurance
Edge Pharma LLC is recalling Vancomycin HCl sterile ophthalmic solution for injection due to lack of assurance of sterility. The affected product was 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: This is an FDA Class II recall of a sterile pharmaceutical product for intraocular injection. Non-sterile injectable drugs intended for direct administration into the eye pose significant risk of serious infection, blindness, and other serious injury, even without reported illnesses in this notice. FDA Class II recalls of sterile drug products are classified as Severe per the rubric.
Plain-English summary
Edge Pharma LLC is recalling Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivalent), 0.8 mL per syringe in single-use syringes for intraocular injection. The recall is due to lack of assurance of sterility.
The product was distributed nationwide. A total of 3,360 syringes are affected. The product is intended for injection into the eye and is manufactured by Edge Pharma LLC, located at 856 Hercules Dr., Colchester, VT, 05446.
Patients who have received this product or healthcare providers who have dispensed it should take appropriate action. Consumers with questions should contact their healthcare provider or pharmacist regarding the use of this product.
The recalled product
- Product
- Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivalent), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0736-01
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Injectable / Ophthalmic
- Hazard
- lack-of-sterility
- infection-risk
- contamination
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@2 12/12/2021 & 09-2021-20@4 01/02/2022
Distribution
Distributed nationwide across the United States.
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