FDAClass IIFebruary 7, 2018

Mitomycin 40 mg/mL Preservative Free Irrigation Volume recall: Labeling Error

Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wachee, FL 34613…

Why was Mitomycin 40 mg/mL Preservative Free Irrigation Volume recalled?

Labeling: Label Error on Declared Strength

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: MIT100217SVDS BUD: 03/01/2018

Product
Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wachee, FL 34613…
Recalling firm
Premier Pharmacy Labs Inc
Quantity
193 vials
Distribution
Nationwide.
Recall date
February 7, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls