Recalls / Class II
Class IID-1257-2019
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
- Affected lot / code info
- Lot #: 02212019@13, Exp 5/22/19
Why it was recalled
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Recalling firm
- Firm
- Customceutical Compounding
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 4611 E Shea Blvd Bldg 3 Ste 180, N/A, Phoenix, Arizona 85028-4258
Distribution
- Quantity
- 16 vials
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2019-04-08
- FDA classified
- 2019-04-30
- Posted by FDA
- 2019-05-08
- Terminated
- 2023-05-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1257-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.