Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles. Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-015-01
Reported: June 14, 2017 Initiated: April 19, 2017 #D-0893-2017
Product Description
Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles. Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-015-01
Reason for Recall
CGMP deviations- Lack of Quality Assurance
Details
- Recalling Firm
- Qualgen
- Units Affected
- 6,227 pellets
- Distribution
- Nationwide.
- Location
- Edmond, OK
Frequently Asked Questions
What product was recalled? ▼
Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles. Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-015-01. Recalled by Qualgen. Units affected: 6,227 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-0893-2017.
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