FDAClass IIMay 8, 2019

HCG (chorionic Gonadotropin 1000 Iu/ml PEP 25 Mg/ml) recall: Sterility Concern

HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL multidose vial compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180…

Why was HCG (chorionic Gonadotropin 1000 Iu/ml PEP 25 Mg/ml) recalled?

Lack of assurance of sterility for injectables and solutions intended to be sterile.

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 #: 03132019@23, Exp 5/12/19

Product
HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL multidose vial compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180…
Recalling firm
Customceutical Compounding
Quantity
12 vials
Distribution
U.S.A. Nationwide
Recall date
May 8, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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