D-0894-2017 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
- 4,883 pellets.
Product Description
Estradiol 12.5 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: 69761-012-01
Reason for Recall
CGMP deviations- Lack of Quality Assurance
Distribution Pattern
Nationwide.
Code Information
Lot# C044; Exp. 03/14/18 Lot# C013; Exp. 07/23/17 Lot# B150; Exp. 12/6/17 Lot# B119; Exp. 10/18/17 Lot# B097; Exp. 09/14/17 Lot# B061; Exp. 07/5/17