D-1257-2019 Class II Terminated
FDA drug recall D-1257-2019 was initiated by Customceutical Compounding on April 8, 2019 and is designated Class II. Reason for recall: Lack of assurance of sterility for injectables and solutions intended to be sterile. The recall status is terminated (terminated May 19, 2023). Affected quantity: 16 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- May 8, 2019
- Initiation Date
- April 8, 2019
- Termination Date
- May 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 vials
Product Description
Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYDROXOCOBALAMIN 500 MC/ML DEXPANTHENOL 50 MG/ML PYRIDOXINE HCL 50 MG/ML), 10 ML MULTIDOSE VIAL INJ COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
Reason for Recall
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot #: 02212019@13, Exp 5/22/19