PlainRecalls
FDA Drug Moderate Class II Terminated

Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-020-01

Reported: June 14, 2017 Initiated: April 19, 2017 #D-0891-2017

Product Description

Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-020-01

Reason for Recall

CGMP deviations- Lack of Quality Assurance

Details

Recalling Firm
Qualgen
Units Affected
4,468 pellets.
Distribution
Nationwide.
Location
Edmond, OK

Frequently Asked Questions

What product was recalled?
Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-020-01. Recalled by Qualgen. Units affected: 4,468 pellets..
Why was this product recalled?
CGMP deviations- Lack of Quality Assurance
Which agency issued this recall?
This recall was issued by the FDA Drug on June 14, 2017. Severity: Moderate. Recall number: D-0891-2017.