FDA recall D-1832-2015

Eagle Pharmacy, Inc. · Class II · drug

Product

LIPO B STERILE INJECTION 10 mL ( Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine Hydrochloride 5 mg, Methylcobalamin 0.1mg, Benzyl Alcohol, Sterile Water, Sodium Hydroxide, Hydrochloric Acid), Multidose vial, Rx Only, Compounded by Eagle Pharmacy, Birmingham, AL 35244

Reason for recall

Subpotent Drug: trace amounts of methylcobalamin in compounded drug.

Distribution

TN, AL

Key facts

Status: Terminated
Initiation date: 2015-08-28
Report date: 2015-10-07
Termination date: 2015-11-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Hoover, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1832-2015