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.
Other recalls by Fresenius Kabi Usa
- Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Il…
FDA Drug · Class I · 2026-09-02 · Fresenius Kabi Usa - Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fre…
FDA Drug · Class I · 2026-08-26 · Fresenius Kabi Usa - Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius K…
FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa - Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius K…
FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa - Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi…
FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa
All Fresenius Kabi Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-379-2014%22
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