FDAClass IIApril 8, 2020

C-*Vancomycin Opthal 14 mg drops recall: Sterility Concern

C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 67457-0340-01.

Why was C-*Vancomycin Opthal 14 mg drops recalled?

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

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?

Lot: 03042020@7 BUD: 03/18/2020

Product
C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 67457-0340-01.
Recalling firm
Medical Center Pharmacy, Inc.
Quantity
1 bottle
Distribution
Specific prescriptions to patients in TN
Recall date
April 8, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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