FDA Drug recall D-688-2013
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 6017…
- FDA Drug
- Class III
- terminated
- Published 2013-07-17
On 2013-07-17 the FDA classified a Class III recall of 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 6017… by Fresenius Kabi Usa, citing failed Impurities/Degradation Specification.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-688-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-05-21 |
| Published | 2013-07-17 |
| 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 Specification
Identifiers
| code_info | Lot #: 6103883, Exp 10/2013 |
|---|
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-688-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.