Drug product
HCG 1000 units/mL, packaged in a) 2 mL and b) 6 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
D-0639-2018
Product summary
- Event
- Event 79619
- Status
- Terminated
- Classification
- Class II
- Quantity
- four vials
- Official record key
drug-enforcement:D-0639-2018
Official wording
Reason: Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Code information: a) Lot#: 20180219@6, BUD 04/05/2018; b) 20180207@14, BUD 03/24/2018; 0180214@22, BUD 03/31/2018; 20180220@7, BUD 04/06/2018.
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.