FDA recall D-1049-2013

Product

Lipo-Injection w/ Lidocaine (PF), Ascorbic Acid 50 mg; B1-50 mg; B2-5-PO4-5 mg; B3-50 mg; B5-5 mg; B6-5 mg; Cyano B12-100 mcg; Methionine 12.5 mg; Inositol-25 mg; Choline-25 mg; Lidocaine 10 mg/mL, 30 mL, Medaus Pharmacy 1-800-526-9183

Reason for recall

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-08-23

Report date

2013-09-25

Termination date

2014-07-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Birmingham, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1049-2013