FDA recall D-688-2013
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 Specification
Distribution
Nationwide and Puerto Rico
Key facts
- Status
- Terminated
- Initiation date
- 2013-05-21
- Report date
- 2013-07-17
- Termination date
- 2015-05-11
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Lake Zurich, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-688-2013