FDA Drug recall D-804-2013
Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Phar…
- FDA Drug
- Class II
- terminated
- Published 2013-07-24
On 2013-07-24 the FDA classified a Class II recall of Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Phar… by Fresenius Kabi Usa, citing subpotent Drug; 15-month stability test station.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-804-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-24 |
| Published | 2013-07-24 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
Product
Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01.
Reason
Subpotent Drug; 15-month stability test station
Identifiers
| code_info | Lot #: 6003648, Exp. 6/2013 |
|---|
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-804-2013%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.