D-0892-2017 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
- 6,361 pellets.
Product Description
Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-018-01.
Reason for Recall
CGMP deviations- Lack of Quality Assurance
Distribution Pattern
Nationwide.
Code Information
Lot# C018; Exp. 08/2/17 Lot# B151; Exp. 12/7/17 Lot# B108; Exp. 10/3/17 Lot# B095; Exp. 09/12/17 Lot# B062; Exp. 07/6/17 Lot# B035; Exp. 05/2/17 Lot# B133; Exp. 11/4/17