FDAClass IIMarch 11, 2020

Human Chorionic Gonadotropin recall: Sterility Concern

Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABLE, For IM, SC Use, Refrigerate,10 mL Multi-dose Vial, Rx only, Axia…

Why was Human Chorionic Gonadotropin recalled?

Lack of Assurance of Sterility

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 #: 07222019+52720, Exp 1/28/2020; 09182019+52923, Exp 3/26/2020; 10232019+53148, Exp 2/28/2020; 11142019+53243, Exp 5/22/2020

Product
Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABLE, For IM, SC Use, Refrigerate,10 mL Multi-dose Vial, Rx only, Axia…
Recalling firm
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Quantity
N/A
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
Recall date
March 11, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls