D-379-2014 Class III Terminated
FDA drug recall D-379-2014 was initiated by Fresenius Kabi USA, LLC on Dec 6, 2013 and is designated Class III. Reason for recall: Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point The recall status is terminated (terminated May 21, 2015). Affected quantity: 215,340 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 25, 2013
- Initiation Date
- Dec 6, 2013
- Termination Date
- May 21, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 215,340 vials
Product Description
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 Pattern
Nationwide, Puerto Rico, Canada, New Zealand
Code Information
Lot 6104649, Exp. 02/14; 6104789, Exp. 03/14; 6105069, Exp. 04/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-379-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026