Drug product
Methionine15mg/Inositol 50mg/Choline 100mg, packaged in a) 5mL and b) 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
D-0641-2018
Product summary
- Event
- Event 79619
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 vials
- Official record key
drug-enforcement:D-0641-2018
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 #: 20180129@18, BUD 4/14/2018 b) Lot #: 20171127@6, 20180207@12, 20180108@16, BUD 04/14/2018.
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.