FDA recall D-1389-2014

Product

Liver Derivative Complex for injection, each mL contains: Liver Derivative Complex 25.5mg, also contains: Water for Injection, Phenol 0.5%, HCl or NaOH to adjust pH, 10 mL, Compounded by Prescription: JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234

Reason for recall

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-05-12

Report date

2014-06-25

Termination date

2014-07-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Nashville, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1389-2014