D-0893-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 14, 2017
- Initiation Date
- April 19, 2017
- Termination Date
- September 24, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,227 pellets
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
Distribution Pattern
Nationwide.
Code Information
Lot# C028; Exp. 02/28/18 Lot# C005; Exp. 07/11/17 Lot# B142; Exp. 11/21/17 Lot# B114; Exp. 10/10/17 Lot# B099; Exp. 09/16/17 Lot# B069; Exp. 07/12/17 Lot# B048; Exp. 06/6/17