FDA Drug recall D-379-2014
FOLIC ACID INJECTION, USP
- FDA Drug
- Class III
- terminated
- Published 2013-12-25
On 2013-12-25 the FDA classified a Class III recall of FOLIC ACID INJECTION, USP by Fresenius Kabi Usa, citing failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-379-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-12-06 |
| Published | 2013-12-25 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
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
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
Identifiers
| code_info | Lot 6104649, Exp. 02/14; 6104789, Exp. 03/14; 6105069, Exp. 04/14 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-379-2014%22
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