Reported Feb 2, 2022 · Terminated
Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin…
Edge Pharma, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edge Pharma, LLC · 856 Hercules Dr · Colchester, VT · 05446-8014
Is this the product you have?
- 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
- Lot codes and dates
- 08-2021-31@2 12/12/2021 & 09-2021-20@4 01/02/2022
- Amount recalled
- 3360 syringes
This recall covers 56 products
The agency filed one notice per product. You are reading one of them; the other 55 are below.
43 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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