FDAFDA · Food and drugs·Recall number D-0891-2017
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
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# C022; Exp. 08/21/17 Lot# B143; Exp. 11/22/17 Lot# B104; Exp. 09/27/17 Lot# B073; Exp. 08/1/17 Lot# B052; Exp. 06/13/17
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States