Drug product
Progesterone 50 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 twist top surrounded by a wrapper,
D-0650-2018
Product summary
- Event
- Event 79619
- Status
- Terminated
- Classification
- Class II
- Quantity
- five vials
- Official record key
drug-enforcement:D-0650-2018
Official wording
Reason: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Code information: Lot#: 20171220@10, BUD 06/18/201; 20171017@83, BUD 04/15/2018; 20171102@40, BUD 05/01/2018; 20180118@97, BUD 07/17/2018; 00180213@32, BUD 08/12/2018.
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.