FOLIC ACID INJECTION — Class III drug recall D-379-2014
Terminated recall by Fresenius Kabi USA, LLC, reported 2013-12-25, distributed nationwide. Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
| Recall number | D-379-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2013-12-06 |
| Classified | 2013-12-18 |
| Reported by FDA | 2013-12-25 |
| Terminated | 2015-05-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, NZ |
| Quantity | 215,340 vials |
| Reason classes | specification failure |
| NDC | 63323-0184-11 |
| Lot numbers | 02/14, 03/14, 04/14, 6104649, 6104789, 6105069 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-379-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.