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.
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