Drug product
Pregnenolone 100 mg (SD) pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
D-0649-2018
Product summary
- Event
- Event 79619
- Status
- Terminated
- Classification
- Class II
- Quantity
- one vial
- Official record key
drug-enforcement:D-0649-2018
Official wording
Reason: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Code information: Lot#: 20171017@85, BUD: 04/15/2018
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.