FDAClass IIJune 15, 2016

Estradiol Cypionate 10 Mg/ml recall: Sterility Concern

ESTRADIOL CYPIONATE 10 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Why was Estradiol Cypionate 10 Mg/ml recalled?

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and 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 #: 03302016:68@10, Exp.06/28/2016; Lot #: 03082016:83@38, Exp. 06/06/2016; Lot #:02172016:37@51, Exp. 5/17/2016; Lot #: 2102016:80@55, Exp.5/30/2016

Product
ESTRADIOL CYPIONATE 10 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Recalling firm
Well Care Compounding Pharmacy
Quantity
869 Units (Total All Products)
Distribution
NV
Recall date
June 15, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls