Folic Acid Injection — Class III drug recall D-688-2013
Terminated recall by Fresenius Kabi USA, LLC, reported 2013-07-17, distributed nationwide. Failed Impurities/Degradation Specification
| Recall number | D-688-2013 |
|---|---|
| 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 | 2013-05-21 |
| Classified | 2013-07-08 |
| Reported by FDA | 2013-07-17 |
| Terminated | 2015-05-11 |
| Distributed | Nationwide (US) |
| Quantity | 80,480 vials |
| Reason classes | specification failure |
| NDC | 63323-0184-11 |
| Lot numbers | 6103883 |
| Expiration dates | 2013-10 |
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
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-688-2013. 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.