Drug product
Estradiol 20 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
D-0676-2018
Product summary
- Event
- Event 79619
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0676-2018
Official wording
Reason: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Code information: Lot#: 20180129@15, BUD 07/28/2018; 20171207@83, BUD 06/05/2018; 20171016@27, BUD 04/14/2018; 20171204@15, BUD 06/02/2018; 20171006@57, BUD 04/04/2018; 20171018@62, BUD 04/16/2018; 20180116@24, BUD 07/15/2018.
Distribution pattern: NV only
Derived failure modes
-
Unknown
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.