FDAClass IIFebruary 20, 2019

HCG, Human chorionic gonadotropin 2,000 units recall: Sterility Concern

HCG, Human chorionic gonadotropin 2,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

Why was HCG, Human chorionic gonadotropin 2,000 units recalled?

Lack of sterility assurance.

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?

Lots: 07172018@15 BUD: 1/13/2019; 08272018@3 BUD: 2/23/2019

Product
HCG, Human chorionic gonadotropin 2,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Recalling firm
Promise Pharmacy, LLC
Quantity
819 vials
Distribution
Nationwide in the USA.
Recall date
February 20, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls