FDA recall D-1395-2014

Product

Levocarnitine Solution for injection, l-Carnitine 50 mg, Also Contains Sterile Water for Injection and Benzyl Alcohol pH adjusted with HCl, 50 mL, 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-1395-2014