FDA recall D-1208-2016

Product

LIPO-INJECTION W/METHYL B12 500 MCG/CARNITINE/NO VIT C W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5 PHOS-5MG, B-3-50MG, B5-5MG, B6-5MG, METHYL B12-500MCG, LIDOCAINE-10MG, CARNITINE 25MG, METHIONINE 12.5 MG, INOSITOL 25MG, CHOLINE CHL 25MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY

Reason for recall

Lack of Assurance of Sterility

Distribution

U.S. Nationwide, Japan, and New Zealand.

Key facts

Status

Terminated

Initiation date

2016-05-13

Report date

2016-07-20

Termination date

2017-06-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Birmingham, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1208-2016