FDAFDA · Food and drugs·Recall number D-0890-2017
Estradiol 22 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 69761-022-01
Published June 14, 2017 · Recall initiated: April 19, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP deviations- Lack of Quality Assurance
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Qualgen
- Distributor
- Nationwide.
- Lot
- Lot # B128; Exp. 11/1/17 Lot # B075; Exp. 08/3/17
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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