D-0889-2017 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
- 1,153 pellets.
Product Description
Estradiol 25 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 69761-025-01,
Reason for Recall
CGMP deviations- Lack of Quality Assurance
Distribution Pattern
Nationwide.
Code Information
Lot # C031; Exp. 03/2/18 Lot # B077; Exp. 08/10/17 Lot # B040; Exp. 05/16/17