FDAClass IIJuly 17, 2013

HCG 125iu/0.25ml recall: Sterility Concern

HCG 125iu/0.25ml (550iu/ml), 3500iu and 10,000iu, compounded by Olympia Pharmacy, Orlando, FL

Why was HCG 125iu/0.25ml 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?

500iu Lot A3504 Exp 8/31/13 3500iu Lot C3105 Exp 9/5/13 10000 iu Lot C3611 Exp 9/6/13

Product
HCG 125iu/0.25ml (550iu/ml), 3500iu and 10,000iu, compounded by Olympia Pharmacy, Orlando, FL
Recalling firm
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Quantity
3
Distribution
Nationwide and PR
Recall date
July 17, 2013
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls