FDA recall D-379-2014

Fresenius Kabi USA, LLC · Class III · drug

Product

FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Dose Vial; Rx only; APP Pharmaceuticals, LLC; Schaumburg, IL 60173 NDC 63323-184-11

Reason for recall

Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point

Distribution

Nationwide, Puerto Rico, Canada, New Zealand

Key facts

Status: Terminated
Initiation date: 2013-12-06
Report date: 2013-12-25
Termination date: 2015-05-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-379-2014