FDAClass IIJuly 17, 2013

Tacrolimus recall: Sterility Concern

Tacrolimus (0.02% and 0.03%) drops, compounded by Olympia Pharmacy, Orlando, FL

Why was Tacrolimus 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?

The recall is ongoing. Follow the firm and FDA 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?

C51012 Exp 9/12/13 and C51201 Exp 9/6/13

Product
Tacrolimus (0.02% and 0.03%) drops, compounded by Olympia Pharmacy, Orlando, FL
Recalling firm
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Quantity
2
Distribution
Nationwide and PR
Recall date
July 17, 2013
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls