FDAClass IIJuly 10, 2013

Mitomycin 0.04% solution recall: Sterility Concern

Mitomycin 0.04% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

Why was Mitomycin 0.04% solution recalled?

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

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 number CABDAGAD:25, Exp date: 4/20/2013 and Lot number CABDAGAD:84, Exp date: 4/20/2013.

Product
Mitomycin 0.04% solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
Recalling firm
Clinical Specialties Compounding Pharmacy
Quantity
50ml total
Distribution
FL, GA and SC.
Recall date
July 10, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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