FDAClass IIFebruary 2, 2022

Vancomycin HCl recall: Sterility Concern

Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivalent), 0.8 mL per syringe…

Why was Vancomycin HCl recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

08-2021-31@2 12/12/2021 & 09-2021-20@4 01/02/2022

Product
Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivalent), 0.8 mL per syringe…
Recalling firm
Edge Pharma, LLC
Quantity
3360 syringes
Distribution
nationwide
Recall date
February 2, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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