FDA Drug recall D-1257-2019
Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYDROXOCOBALAMIN 500 MC/ML DEXPANTHENOL 50 MG/ML PYRIDOXINE HCL 5…
- FDA Drug
- Class II
- terminated
- Published 2019-05-08
On 2019-05-08 the FDA classified a Class II recall of Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYDROXOCOBALAMIN 500 MC/ML DEXPANTHENOL 50 MG/ML PYRIDOXINE HCL 5… by Customceutical Compounding, citing lack of assurance of sterility for injectables and solutions intended to be sterile.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1257-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-08 |
| Published | 2019-05-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Customceutical Compounding |
| Distribution | US |
Product
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
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Identifiers
| code_info | Lot #: 02212019@13, Exp 5/22/19 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1257-2019%22
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