FDAClass IINovember 14, 2018

Estradiol 15mg pellet recall: Sterility Concern

Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) vials, Rx…

Why was Estradiol 15mg pellet 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?

Lots: C253 BUD: 12/12/2018; D016 BUD: 1/18/2019

Product
Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) vials, Rx…
Recalling firm
Qualgen, LLC
Distribution
Nationwide.
Recall date
November 14, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls