PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: May 8, 2019 Initiated: April 8, 2019 #D-1257-2019

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.

Details

Units Affected
16 vials
Distribution
U.S.A. Nationwide
Location
Phoenix, AZ

Frequently Asked Questions

What product was recalled?
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. Recalled by Customceutical Compounding. Units affected: 16 vials.
Why was this product recalled?
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 8, 2019. Severity: Moderate. Recall number: D-1257-2019.